FDA-cleared profile
CureMetrix, Inc.
cmAngio processes screening FFDM and DBT mammograms to detect presence or absence of breast arterial calcifications at study and breast level and mark segments for qualified interpreting-physician review; it is not primary breast-cancer interpretation or a standalone diagnostic or treatment decision tool.
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 K232367 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 parallel processing of screening FFDM and DBT and marked outputs; exact DICOM, PACS, worklist, and thumbnail 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 not a primary breast-cancer interpretation tool and is not a standalone diagnosis or treatment decision tool. Qualified physicians must review the complete mammographic study and account for image-quality and acquisition 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 K232367 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 not a primary breast-cancer interpretation tool and is not a standalone diagnosis or treatment decision tool. Qualified physicians must review the complete mammographic study and account for image-quality and acquisition 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.
No single product-level sensitivity value was promoted because the reviewed FDA material is workflow, module, sequence, or population specific.
No single product-level specificity value was promoted because the reviewed FDA material is workflow, module, sequence, or population specific.
No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.
FDA 510(k) verification and validation evidence described in the exact submission · Breast; breast arterial calcifications
exact submission · Tested version: cmAngio V1.0 · Sponsor or vendor studyK232367
Manufacturer evidence submitted for the exact FDA decision. It is not independent clinical validation, and local technical, clinical, privacy, security, and workflow acceptance remains necessary.
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 one PubMed title. It concerns a breast arterial-calcification nomogram but does not identify cmAngio V1.0 or K232367, so it is quarantined. The current discovery snapshot contains 1 PubMed and 0 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, fda decision summary, 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.
Alternatives
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...
CureMetrix, Inc.
cmAngio (V1.6) processes screening mammograms to aid a qualified interpreting physician in the manual process of identifying breast arterial calcification. It detects the presence...
DeepHealth, Inc.
Concurrent detection and characterization support for screening DBT mammography
Lunit, Inc.
Lunit INSIGHT MMG v1.1.10 aids physicians in detection, localization and characterization of suspicious breast-cancer areas on female screening mammograms from compatible FFDM...