FDA-cleared profile
Matakina Technology LTD
Volpara processes raw data from digital breast x-ray systems, including tomosynthesis, to calculate density maps, volumetric breast density, and BI-RADS breast-density categories as adjunctive information for an MQSA-qualified interpreting physician.
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.
Normalized from the prior exact-submission review. Confirm interface versions and local compatibility during technical evaluation.
Deployment category preserved from the prior exact-submission review; hosting region, data flow, and current commercial configuration still require vendor confirmation.
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 K153427 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 exact local interoperability contract remains unverified; test supported inputs, outputs, identifiers, routing, archive behavior, and failure handling locally.
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 adjunctive and not interpretive or diagnostic. The MQSA-qualified interpreting physician remains responsible for the final breast-density category and clinical interpretation; compatible raw data and acquisition limits apply.
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 K153427 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 adjunctive and not interpretive or diagnostic. The MQSA-qualified interpreting physician remains responsible for the final breast-density category and clinical interpretation; compatible raw data and acquisition limits apply.
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
exact submission · Tested version: Volpara Imaging Software 1.5.2 · Sponsor or vendor studyK153427
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 three PubMed titles. They concern volumetric mammographic density but do not identify Volpara Imaging Software 1.5.2 or K153427, so all three are quarantined. The current discovery snapshot contains 3 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.
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