ModifiedUnitedHealthcarePolicy CSNCT0375.06

Breast Imaging for Screening and Diagnosing Cancer (for North Carolina Only)

This policy governs coverage of breast imaging modalities for screening and diagnosis of breast cancer for UnitedHealthcare members in North Carolina, including indications for MRI and statements about technologies considered unproven.

Policy Summary

PayerUnitedHealthcare

PolicyBreast Imaging for Screening and Diagnosing Cancer (for North Carolina Only)

Policy CodePolicy CSNCT0375.06

Change TypeRevised coverage criteriaadded gene-specific agesremoved select codes

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionObtain and retain medical record documentation that supports medical necessity (history, exam, and pertinent test results) for prior authorization and claims review.

SourceLink

POLICY UPDATE CHANGES

Revised list of proven and medically necessary indications including removal of diagnostic breast ultrasound and digital mammography for dense breasts; revised MRI high-risk criteria and added/changed gene-specific screening ages

Removed language indicating this policy does not address routine preventive breast cancer screening using conventional mammography

Removed automated breast ultrasound system and electrical impedance scanning from unproven and not medically necessary services

Removed CPT codes 76499, 76641, and 76642 from Applicable Codes

Added definition of 'Breast Composition Categories'

North Carolina onlypolicy application

2026-05-01policy revision date

77046-77049

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

14.2-16.5/1000CDR incremental (MRI vs mammography)

3 CPT codescodes removed

20+high-risk indications listed

Coverage Criteria

Covered: Breast MRI for high-risk individuals

MRI of the breast is proven and medically necessary for individuals who are high risk for breast cancer as defined by ANY of the following:

High-risk indications for breast MRI: Heterogeneously dense breasts (Category C) or extremely dense breasts (Category D)screening beginning at age 40

From policy: proven and medically necessary for Category C/D

Prior thoracic radiation therapy between the ages 10 and 30screening starting at age 25 or 8 years after treatment, whichever is later

Policy specifies timing rule for start of MRI screening

Lifetime risk models: Lifetime risk estimated ≥ 20% per family-history dependent models (e.g., Gail, Claus, Tyrer-Cuzick, BRCAPRO)>= 20%

Lifetime risk threshold defined in policy

Personal history of breast cancer (not treated with bilateral mastectomy)N/A

Included as a high-risk indication in policy

Personal pathogenic variants

Example: gene-specific screening ages: ATM, CDH1, CHEK2, NF1, PALB2, PTEN, STK11: screening beginning at age 30; BARD1, RAD51C, RAD51D: screening beginning at age 40; BRCA1/BRCA2: screening beginning at age 25; TP53: screening beginning at age 20age-based
Gene-specific ages taken from policy

Medically Necessary / High-Risk Screening

Revised proven and medically necessary indications and high-risk screening criteria (summary of changes):

High-risk MRI screening criteria (summary): MRI of the breast is covered for individuals at high risk for breast cancer with specified gene mutations, family-history patterns, prior thoracic radiation, dense breasts, personal history, or elevated lifetime risk; screening ages and timing were revised in this policy update.see gene-specific and family-history rules

Policy revision 05/01/2026 updated gene list, ages, and prior radiation timing

Gene-specific screening ages (examples): BRCA1/BRCA2: screening beginning at age 25; TP53: screening beginning at age 20; ATM, CHEK2, PALB2, NF1, PTEN, STK11: screening beginning at age 30; BARD1, RAD51C, RAD51D: screening beginning at age 40.age-based per gene

Explicit gene-age mappings added or revised in 05/01/2026 policy history

Prior thoracic radiation (revised):

Supplemental imaging per guideline-based risk stratification

Guideline-based supplemental imaging for screening/diagnostic recall:

Preferred supplemental imaging for high-risk individuals: Guidelines (ACR, NCCN, ACOG, EUSOBI, ACS) recommend supplemental imaging selectively: breast MRI is the preferred supplemental modality for high-risk patients; annual MRI is appropriate for many high-risk individuals.per guideline recommendations

ACR and NCCN guidance cited in policy

Alternatives when MRI cannot be performed: When MRI is contraindicated or unavailable, consider contrast-enhanced mammography (CEM) or molecular breast imaging (MBI); whole-breast ultrasound may be used if contrast-enhanced or functional imaging is not available.N/A

NCCN and ACR note alternatives to MRI for high-risk patients

Supplemental imaging for diagnostic recall: For diagnostic work-up of screen-recalled lesions, CEM and MRI demonstrate high sensitivity; supplemental imaging increases cancer detection but also increases recall and biopsy rates.

Molecular Breast Imaging / Scintimammography

Molecular imaging adjuncts:

MBI/BSGI/Scintimammography as adjuncts: Molecular breast imaging and scintimammography have shown relatively high sensitivity and specificity as adjuncts to mammography but studies are limited by bias, heterogeneous populations, and higher radiation exposure; current evidence does not support routine population screening and further high-quality studies are needed.N/A

Multiple systematic reviews and meta-analyses summarized in policy; SNMMI/EANM guideline notes potential utility in dense breasts but cautions on radiation

Breast CT (including cone beam breast CT)

Investigational/Not established:

Breast CT investigational: Computed tomography of the breast (including cone beam breast CT) is considered investigational and has inconclusive evidence for routine breast cancer screening; further large-scale prospective validation is required before routine clinical use.N/A

ECRI and Uhlig 2019 systematic review conclude evidence is inconclusive and additional studies are needed

Breast CT not routine screening: Routine use of breast CT (including cone beam breast CT) for population screening is not supported by current evidence and is considered not medically necessary for routine screening.N/A

Policy lists CT of the breast as unproven and not medically necessary

Magnetic Resonance Elastography (MRE)

Promising but not yet standard:

Magnetic Resonance Elastography (MRE): Magnetic resonance elastography can quantify tissue stiffness and may help stratify risk in women with dense breasts; combining MRE with contrast-enhanced MRI may improve diagnostic accuracy, but larger validation studies are required before routine clinical adoption.N/A

Feasibility and small prospective studies (Patel 2022, Siegmann 2010) suggest associations with risk and improved diagnostic performance but require further validation

MRI of the breast for individuals who do not meet the specified high-risk criteria listed in this policy is considered unproven and not medically necessary. This includes requests for screening MRI based solely on breast density without any of the defined high-risk features (genetic mutations, qualifying family history patterns, prior chest radiation within the specified age window, or lifetime risk estimates meeting the policy threshold).

The following modalities are identified in the policy as unproven or not medically necessary for routine breast cancer screening or as insufficiently established adjuncts: Computer-Aided Tactile Breast Imaging, Computed Tomography (CT) of the breast (including cone beam breast CT), and Magnetic Resonance Elastography (MRE). The document notes that further well-designed studies are needed to validate clinical usefulness of breast CT and that MRE remains investigational pending larger validation studies.

Breast CT (including cone beam breast CT) and molecular imaging techniques such as Breast-Specific Gamma Imaging (BSGI)/Molecular Breast Imaging (MBI) are not supported for routine screening. Guideline statements and professional society guidance cite limited or inconclusive evidence for CT-based breast screening and note that MBI/BSGI currently have a relatively higher radiation dose, prompting recommendations against their routine use for population screening.

Current evidence does not support the routine population use of molecular imaging (MBI/BSGI/PEM) for breast cancer screening. Systematic reviews and guideline statements conclude these techniques may detect mammographically occult cancers in selected settings (for example, dense breasts or when MRI is not possible) but are limited by heterogeneous studies and potential bias; additionally, molecular imaging typically imparts a substantially higher whole-body radiation dose than mammography, reducing support for routine screening application.

Policy revisions removed automated breast ultrasound systems and electrical impedance scanning (EIS) from the list of unproven technologies. The policy restates that breast MRI remains covered only for individuals who meet the defined high-risk criteria (gene-specific ages, prior thoracic radiation timing, lifetime risk thresholds, qualifying family history, etc.), and that MRI for persons who do not meet those criteria is considered not medically necessary.

Covered Indications

Breast MRI — screening in high-risk individuals

Breast MRI — screening in high-risk individuals:

Top-level: screening in high-risk individuals: Breast MRI is appropriate and covered for individuals meeting any of the high-risk criteria listed in policy (dense breasts Category C/D, prior thoracic radiation, lifetime risk ≥20% by validated models, personal history of breast cancer, specified pathogenic variants, or qualifying family-history patterns).see individual criteria for age/timing details

Policy lists high-risk indications and screening start ages; see gene-specific entries and family-history rules

Supplemental screening in high-risk patients or select subgroups (dense breasts, genetic predisposition, prior chest irradiation)

Supplemental screening in high-risk patients or select subgroups (dense breasts, genetic predisposition, prior chest irradiation):

Guideline-supported supplemental screening: For high-risk patients and selected subgroups (e.g., extremely/heterogeneously dense breasts, genetic predisposition, prior chest irradiation), supplemental screening with MRI is preferred; CEM, MBI, or whole-breast ultrasound may be considered when MRI is not feasible.

Coding

Applicable CPT/HCPCS Codes (reference)mixed

0422T	Tactile breast imaging by computer-aided tactile sensors, unilateral or bilateral.
0633T	Computed tomography, breast, including 3D rendering, when performed, unilateral; without contrast material.
0634T	Computed tomography, breast, including 3D rendering, when performed, unilateral; with contrast material(s).
0635T	Computed tomography, breast, including 3D rendering, when performed, unilateral; without contrast, followed by contrast material(s).
0636T	Computed tomography, breast, including 3D rendering, when performed, bilateral; without contrast material(s).
0637T	Computed tomography, breast, including 3D rendering, when performed, bilateral; with contrast material(s).
0638T	Computed tomography, breast, including 3D rendering, when performed, bilateral; without contrast, followed by contrast material(s).
76376	3D rendering with interpretation and reporting of CT, MRI, ultrasound, or other tomographic modality with image postprocessing under concurrent supervision; not requiring image postprocessing on an independent workstation.
76377	3D rendering with interpretation and reporting of CT, MRI, ultrasound, or other tomographic modality with image postprocessing under concurrent supervision; requiring image postprocessing on an independent workstation.
76391	Magnetic resonance (e.g., vibration) elastography.

1–10 of 16

1/2

Removed CPT CodesCPT

76499	Removed from Applicable Codes
76641	Removed from Applicable Codes
76642	Removed from Applicable Codes

inv-16: MRI screening age thresholds — example age thresholds by genetic mutation / risk factor

BRCA1 / BRCA2Screening beginning at age 25

TP53 (Li-Fraumeni syndrome)Screening beginning at age 20

ATM, CHEK2, PALB2, NF1, PTEN, STK11Screening beginning at age 30

BARD1, RAD51C, RAD51DScreening beginning at age 40

Prior thoracic radiationScreening starting at age 25 or 8 years after treatment, whichever is later

inv-17: Lifetime risk models threshold — lifetime risk >= 20% used as a threshold in guidelines

Provider Actions

Billing Rule

Applicable MRI and Related Codes

Applicable MRI and related CPT codes (77046-77049) are referenced for provider billing and authorization. Note: computer-aided detection (CAD) is included in CPT 77048 and 77049; if CAD is performed with these MRI breast codes, do not bill separately for CAD.

Covered/Referenced CPT codes: 77046, 77047, 77048, 77049

Prior Authorization

Prior Authorization for Supplemental Imaging

Prior authorization may be required for supplemental breast imaging (breast MRI, contrast-enhanced mammography [CEM], molecular breast imaging [MBI], and other specialty imaging) depending on the indication. Prior authorization is more likely to be required when imaging is requested outside guideline-specified high-risk indications (e.g., for routine screening in average-risk patients).

Prior Authorization

Adhere to payer authorization procedures and documentation guidance

Follow payer guidance on prior authorization and documentation to avoid preventable denials or claim delays.

Prior Authorization

Prior authorization may be required for supplemental MRI/CEM/MBI

UnitedHealthcare may require prior authorization for breast MRI, CEM, or MBI when these modalities are used for supplemental screening outside of guideline-specified high-risk indications.

Documentation Required

Plan/contract may require documentation before approval

Medical record documentation may be required prior to approval for any specialty breast imaging, depending on plan or contractual rules.

Contrast Rules

Billing Rule

Map CPT breast MRI codes to contrast usage

Use the MRI breast CPT code set (77046–77049) consistent with contrast use: 77046/77047 denote without contrast; 77048/77049 denote without and with contrast and include CAD when performed.

Billing Rule

CE-CBBCT contrast protocols varied; CE-CBBCT shows higher pooled performance

Contrast-enhanced cone beam breast CT (CE-CBBCT) protocols varied across studies; limited data indicate CE-CBBCT has higher pooled sensitivity and specificity than non-contrast CBBCT in published analyses.

Billing Rule

Document contrast use for CEM and contrast-enhanced MRI

Document use of contrast for contrast-enhanced modalities (CEM or contrast MRI) because contrast-enhanced techniques can increase cancer detection in high-risk populations and carry specific risks (e.g., iodinated contrast reactions).

Definitions

inv-31: Breast Composition Categories — ACR BI-RADS density categories (definition added in policy)

Category AAlmost entirely fatty

Category BScattered areas of fibroglandular density

Category CHeterogeneously dense

Category DExtremely dense

inv-40: Breast Composition Categories — policy-specific definition entry (duplicate/additional reference)

Policy-specific term'Breast Composition Categories' — levels of breast tissue density used in screening decisions (ACR BI-RADS Categories A–D)

Use in screening

Background

Mammography (digital mammography/DBT per applicable guidelines) is the accepted standard screening method for breast cancer. Adjunctive modalities such as MRI, ultrasound, CT, and molecular imaging have been investigated to address limitations of mammography (for example, in dense breasts or in high-risk individuals), but their use is guided by individualized risk assessment and professional society recommendations rather than routine substitution for mammography.

Plan / Contractual Considerations

Note

Check federal/state/contract rules and payer tools when applying policy

Refer to federal, state, or contractual benefit requirements when determining coverage; UnitedHealthcare may modify policies and uses third-party tools (e.g., InterQual) to assist benefits administration.

Revision History

2026-05-01policy_revisionLatest

Revised coverage rationale and high-risk MRI criteria: removed diagnostic breast ultrasound and digital mammography for dense breasts; added/modified gene-specific MRI screening ages (e.g., BRCA1/2 start at 25, TP53 at 20, ATM/CHEK2/PALB2/NF1/CDH1/STK11/PTEN at 30, BARD1/RAD51C/RAD51D at 40) and clarified prior thoracic radiation timing (screening at age 25 or 8 years after treatment, whichever is later).

Policy Summary

PayerUnitedHealthcare

PolicyBreast Imaging for Screening and Diagnosing Cancer (for North Carolina Only)

Policy CodePolicy CSNCT0375.06

Change TypeRevised coverage criteriaadded gene-specific agesremoved select codes

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionObtain and retain medical record documentation that supports medical necessity (history, exam, and pertinent test results) for prior authorization and claims review.

SourceLink

On This Page

Individuals with prior thoracic radiation between ages 10 and 30 are eligible for MRI screening starting at age 25 or 8 years after treatment, whichever is later.

start at max(25, treatment_date + 8 years)

Replaced prior criterion to clarify screening start time per revision history

Lifetime risk definition (revised): Individuals with lifetime risk estimated ≥ 20% by family-history dependent models (e.g., Gail, Claus, Tyrer-Cuzick, BRCAPRO) are included as high risk for supplemental imaging consideration.>=20%

Policy history explicitly added the >=20% lifetime risk threshold

Systematic reviews report increased CDR with supplemental MRI/CEM and tradeoffs in recall/biopsy rates

per guideline recommendations

ACR, NCCN, and systematic reviews support selective use of supplemental imaging with tradeoffs in recall/biopsy rates

Supplemental screening when MRI is contraindicated or unavailable

Supplemental screening when MRI is contraindicated or unavailable — alternatives and indications:

Alternatives to MRI for high-risk individuals: If MRI is contraindicated or unavailable for high-risk individuals, consider contrast-enhanced mammography (CEM) or molecular breast imaging (MBI); whole-breast ultrasound may be used if contrast-enhanced or functional imaging is not available.N/A

NCCN and ACR guidance provide alternatives to MRI; SNMMI notes MBI utility in dense breasts but cautions on radiation exposure

Adjunctive screening in dense breasts or when MRI is contraindicated

Adjunctive screening in dense breasts or when MRI is contraindicated:

Adjunct modalities for dense breasts or MRI-ineligible patients: In women with dense breasts or those who cannot undergo MRI, adjunctive modalities such as whole-breast ultrasound, CEM, or MBI may be considered to increase cancer detection, recognizing increased recall and biopsy rates and, for some modalities, higher radiation exposure.N/A

SBI/ACR and NCCN statements support adjunctive use in select situations; balance benefits and harms when selecting modality

Not covered modalities include Computer-Aided Tactile Breast Imaging, Computed Tomography (CT) of the breast (including cone beam breast CT), Magnetic Resonance Elastography (MRE), and requests for MRI of the breast when the individual does not meet the policy's defined high-risk criteria. These services are listed as unproven or not medically necessary due to insufficient evidence of clinical validity or utility.

Routine breast CT (including cone beam breast CT) and routine use of BSGI/MBI for population screening are not covered. The policy cites limited or inconclusive evidence supporting CT-based breast screening and professional society recommendations that do not endorse BSGI/MBI for routine screening because of evidence limitations and radiation concerns.

The policy states that routine use of molecular imaging (e.g., BSGI, MBI, PEM) as population screening is not supported by current evidence. Guideline and society statements note that while molecular imaging can increase detection in certain subgroups, study limitations and a substantially higher whole-body radiation dose compared with mammography argue against routine population screening with these modalities.

Lifetime risk threshold>= 20% as estimated by family-history dependent models (e.g., Gail, Claus, Tyrer-Cuzick, BRCAPRO)

Screening start age for lifetime riskScreening beginning at age 40

Model dependenceRisk estimate derived from models largely dependent on family history

Supplemental modalities subject to prior authorization: breast MRI (77046–77049), abbreviated MRI, CEM, MBI, MRE, breast CT, molecular imaging studies

Denial Risk

Procedures Described as Investigational / Limited Evidence

Some procedures and modalities described in the evidence base remain investigational or unproven (for example breast CT for screening and certain molecular imaging techniques). Claims for procedures described as investigational or without established clinical utility may be denied.

Examples: breast CT for routine screening — evidence inconclusive; molecular breast imaging/PEM — not routinely recommended for screening; MRE and other novel techniques — emerging evidence only

Documentation Required

Medical Record Documentation Requirements

The patient's medical record must contain documentation that fully supports the medical necessity for the requested services. Documentation should include relevant medical history, the clinical breast exam findings, rationale for supplemental imaging (risk assessment, breast density, previous imaging results), and results of pertinent diagnostic tests or procedures. Records must be legible, retained in the patient's chart, and provided upon request. Lack of sufficient supporting documentation may result in denial of the requested services.

Documentation elements commonly requested: date and reason for request, detailed risk assessment (e.g., genetic mutation, lifetime risk %), prior imaging reports (mammography/DBT), physical exam findings, contraindications to MRI if applicable (e.g., incompatible device)
Medical records may be requested during review to confirm that clinical criteria are met

Documentation Required

Imaging Biomarker Documentation

When MRI/MRE studies are performed that report quantitative imaging biomarkers (for example stiffness, elasticity, viscosity from MRE or other quantitative MRI metrics), include the measured values and method used in the report. Quantitative biomarker documentation can support clinical decision-making and may be requested during utilization review.

Report measured biomarker values (e.g., stiffness, elasticity, viscosity) and note breast density, laterality, and comparison to prior values when available
If biomarker thresholds or risk-stratification guidance are used, document the thresholds and how they informed the decision to pursue supplemental imaging

Note

Sequential Imaging Approach

Follow a sequential imaging approach: document prior and concurrent imaging, use least invasive/least exposure modality appropriate to the clinical question, and escalate to contrast-enhanced or functional imaging only when indicated by risk factors, prior findings, or contraindications to other modalities. Prior authorization and documentation requirements apply across the sequence.

Example sequence: diagnostic mammography/DBT → targeted ultrasound (if needed) → contrast-enhanced MRI/CEM or MBI for high-risk or unresolved findings
When MRI is the chosen supplemental modality, ensure contraindications and alternative modalities considered are documented

Categories C and D referenced as indications for supplemental MRI (Category C: heterogeneously dense; Category D: extremely dense)

Reference addedDefinition added to policy during 05/01/2026 revision

inv-32: Breast Specific Gamma Imaging (BSGI) — definition and mechanism

DefinitionBreast Specific Gamma Imaging (BSGI) is a noninvasive diagnostic nuclear medicine technique that detects breast tissue accumulating radioactive tracer using a gamma camera after IV tracer administration

PurposeProposed primarily as an adjunct to mammography and physical exam to improve selection for biopsy in patients with palpable masses or suspicious mammograms

Alternate namesAlso referred to as scintimammography or Molecular Breast Imaging (MBI)

inv-33: Computer-Aided Tactile Breast Imaging — definition of tactile array sensor technique

TechniqueComputer-aided tactile breast imaging uses a hand-held tactile array sensor moved across the breast to collect signals that are processed into multi-dimensional color images in real time

Information providedDisplays size, shape, hardness, and location of suspicious masses immediately for clinician review

Procedure contextSensor data are converted into images while the clinician performs the exam

inv-34: Magnetic Resonance Elastography (MRE) of the Breast — technique definition measuring mechanical properties

TechniqueMagnetic Resonance Elastography (MRE) of the breast is a phase-contrast MRI method that measures mechanical properties of tissue (elastic modulus) by applying a known stressor and measuring resulting deformation

Clinical rationaleMalignant breast tissue typically has substantially higher elastic modulus (5–20×) compared with surrounding fibroglandular tissue

Performance noteRequires specialized electromechanical driver and integrated radiofrequency coil unit in the MRI suite

inv-35: Molecular Breast Imaging (MBI) — definition and brief mechanism

DefinitionMolecular Breast Imaging (MBI) is a functional nuclear medicine procedure using a radioactive tracer and a specialized camera to detect differences in metabolic activity of breast tissue

Adjunct roleEvaluated as an adjunct to mammography to detect mammographically occult cancers, but evidence is limited and methodologic issues exist

Radiation considerationAssociated with higher radiation exposure than mammography; not recommended for routine population screening by some societies

inv-36: Positron Emission Mammography (PEM) — high-resolution metabolic imaging definition

DefinitionPositron Emission Mammography (PEM) is high-resolution metabolic breast imaging using an FDG tracer with detectors integrated into a mammography system

AcquisitionEmission images acquired immediately after the mammogram to provide metabolic information

Clinical statusDescribed as a specialized metabolic imaging modality for breast cancer evaluation

inv-37: Magnetic Resonance Elastography (MRE) — additional definition entry (quantitative stiffness/elasticity/viscosity)

Quantitative measuresMRE provides quantitative measures of tissue stiffness, elasticity, and viscosity that may be associated with breast cancer risk and lesion characterization

Research statusStudied as a biomarker in dense and high-risk populations; clinical benefits remain under evaluation and require further validation

Reporting noteDocumentation of stiffness/elasticity/viscosity metrics is recommended when reporting MRI/MRE studies

inv-38: Contrast-Enhanced Cone Beam Breast CT (CE-CBBCT) — definition and evidence note

DefinitionContrast-Enhanced Cone Beam Breast CT (CE-CBBCT) is a cone beam CT breast imaging technique performed with IV iodinated contrast to improve lesion detection

Evidence noteLimited studies report higher pooled sensitivity (0.899) and specificity (0.788) for CE-CBBCT versus non-contrast CBBCT; protocols for contrast varied across studies

Comparative performanceDiagnostic accuracy of CE-CBBCT was numerically comparable to breast MRI in pooled analyses

inv-39: MBI/BSGI — nuclear medicine-based breast imaging definition using radiotracers

DefinitionMBI/BSGI are nuclear medicine-based breast imaging techniques using radiotracers (e.g., Tc-99m sestamibi) and dedicated gamma cameras to detect metabolically active lesions

Adjunctive useEvaluated as adjuncts to mammography to improve detection in certain scenarios, but evidence limitations and higher radiation dose limit routine use

Society guidanceACR recommends against BSGI/MBI for screening due to relatively high radiation dose and insufficient evidence

inv-41: BSGI — notes on dedicated gamma cameras and FDA device class

Procedure and devicesBSGI uses dedicated gamma cameras; the procedure itself is not FDA-regulated but the equipment is regulated

FDA classificationCameras used for BSGI are considered Class I radiologic devices per FDA

Regulatory noteInformation source: FDA device classification and relevant manufacturer/device records (accessed June 18, 2025)