FDA-cleared profile
DeepHealth, Inc.
BAC processes screening FFDM and DBT mammograms to detect the presence or absence of breast arterial calcifications at study and breast level and localize detected calcifications for qualified interpreting-physician review.
Clinical fit
Start with the authorized purpose, then verify how it fits your service line and reading workflow.
Regulatory identity
The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.
Implementation
Use these fields to structure a vendor demo, security review, and implementation estimate.
The exact installed deployment, hosting, service, and operational boundary is not established by the reviewed public FDA material.
The FDA decision material does not establish the complete security posture for the exact product and deployment. Obtain architecture, identity, audit, encryption, retention, support-access, vulnerability-management, and incident-response evidence.
Map the installed product, build, options, population, anatomy, inputs, outputs, and enabled functions to K254131 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
The exact installed deployment, hosting, service, security, and operational boundary remains unverified and requires site-specific confirmation.
exact submission · checked 2026-09-04FDA-described deployment details do not establish current hosting contracts, security controls, uptime, or local qualification.
The FDA package describes processing of FFDM and DBT studies and localized outputs; exact DICOM, PACS, worklist, and image-return routing require local testing.
exact submission · checked 2026-09-04Test representative identifiers, orientation, geometry, measurements, units, routing, failure handling, and round trips locally.
Use a signed local test set for the supported population and workflow. Include common and difficult cases, exclusions, acquisition variation, failed or low-quality inputs, reviewer overrides, and downstream effects. The software is an adjunct and not a primary breast-cancer interpretation or standalone diagnosis or treatment tool. Qualified physicians must review the complete study and account for acquisition and image-quality limits.
exact submission · checked 2026-09-04Define stop-use, escalation, rollback, and revalidation triggers before production use.
Model capital and recurring cost against net staff time after review, throughput, repeat imaging or rework, infrastructure, training, service, downtime, upgrade, and replacement costs.
product family · checked 2026-09-04No exact-product price or product-specific reimbursement was established in the reviewed public material.
Monitor K254131 by exact software, hardware, model, and algorithm version; patient population; anatomy; protocol; operator; input quality; output edits or overrides; failed studies; repeat acquisition or rework; downstream impact; downtime; incidents; recalls; and updates. Track these product-specific limits: The software is an adjunct and not a primary breast-cancer interpretation or standalone diagnosis or treatment tool. Qualified physicians must review the complete study and account for acquisition and image-quality limits.
exact submission · checked 2026-09-04Revalidate after material software, hardware, model, protocol, interface, or clinical-policy changes.
Evidence
Metrics are shown only when they are tied to a source, endpoint, population, and tested product version.
Study-level and breast-level BAC detection sensitivity in Retrospective blinded multicenter standalone study of screening FFDM.
Tested version: BACStudy-level and breast-level BAC detection specificity in Retrospective blinded multicenter standalone study of screening FFDM.
Tested version: BACStudy-level and breast-level BAC detection sensitivity in Retrospective blinded multicenter standalone study of screening DBT.
Tested version: BACStudy-level and breast-level BAC detection specificity in Retrospective blinded multicenter standalone study of screening DBT.
Tested version: BACRetrospective blinded multicenter standalone performance study described in the FDA decision material · Breast; breast arterial calcifications
exact submission · Tested version: BAC · n=1775 · 37 sites · Sponsor or vendor studyK254131
The FDA material reports 850 FFDM images and 925 DBT images from 37 U.S. sites, with 150/700 FFDM and 169/756 DBT positive/negative cases. These are manufacturer-sponsored retrospective performance results, not independent prospective outcome evidence.
Economics and lifecycle
These are common procurement questions; unknown values remain visible until a source supports them.
No public list price for the exact cleared product version was established. Obtain a written quote separating license, implementation, interfaces, compute, storage, training, support, upgrades, renewal, and exit costs.
No separate named-product payment identified in reviewed CMS material
Centers for Medicare & Medicaid Services · United StatesThis is not a product-specific reimbursement determination. Verify payer, site-of-service, coding, and coverage assumptions independently.
Safety and lifecycle
Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
Screened 20 PubMed titles and 10 trial records. Most are unrelated BAC acronym matches; the breast arterial-calcification papers do not identify DeepHealth BAC, K254131, or its tested release. All 30 are quarantined. The current discovery snapshot contains 20 PubMed and 10 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.
Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.
Source classes: fda ai list, acr ai central product, fda decision material, peer reviewed literature, clinical trial registry, reimbursement policy, fda device recall, pubmed, clinical trials, openfda device recall
Sources
Sources accessed through 2026-09-04.
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