FDA-cleared profile
Siemens Healthcare GmbH
Prostate MR AI (VA10A) is a plug-in CADe/CADx aid for radiologists interpreting prostate MRI in adult men aged 40 years or older with suspected prostate cancer and no prior treatment, using PI-RADS-oriented review; it is not the sole basis for diagnosis or management.
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.
This is the interface boundary described in the exact FDA decision material; current local compatibility, routing, identity, archive, and downtime behavior still require acceptance testing.
This is the release-level boundary described in the exact FDA decision material; current hosting, contracts, security, availability, upgrade path, and site configuration remain separate evidence.
Public materials reviewed for this exact release do not establish the complete security posture. Request data-flow, identity, audit, encryption, retention, remote-access, vulnerability-management, backup, and incident-response evidence.
Buyer-facing monitoring guidance derived from the exact cleared scope; it is not a claim that the FDA package provides a live monitoring service.
Map installed model, build, options, population, anatomy, inputs, outputs, and enabled functions to K241770 before acceptance.
exact submission · checked 2026-09-04Later product-family features are not evidence that this cleared release includes them.
The FDA material describes a separate hosting application or plug-in and a syngo.MR General Engine license; the current host topology, security, service, and local configuration remain unverified.
exact submission · checked 2026-09-04FDA-described deployment boundaries do not establish current hosting contracts, security controls, uptime, or local qualification.
The FDA material describes a plug-in with a separate host application and supported prostate MRI inputs, with displayed contours, maps, scores, and measurements for radiologist review.
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. Use is limited to adult men aged 40 years or older with suspected cancer in a treatment-naive prostate and the supported MRI sequences; radiologist review remains required and the software is not the sole basis for a clinical decision.
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, room time, consumables, infrastructure, training, service, downtime, upgrade, and replacement costs.
product family · checked 2026-09-04No exact-product price was found in the reviewed public material; productivity or value claims require local evidence.
Monitor K241770 by exact hardware, software, model, 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.
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.
Sensitivity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.
Specificity is not promoted as a product-wide endpoint. Compare only an exact endpoint, threshold, population, version, and source if later verified.
Reader-study case-level discrimination in 340-case MRMC prostate MRI study read by 12 ABR radiologists.
Tested version: Prostate MR AI (VA10A) configuration described in K241770Reader-study case-level discrimination with software aid in 340-case MRMC prostate MRI study read by 12 ABR radiologists.
Tested version: Prostate MR AI (VA10A) configuration described in K241770Reported paired reader-study AUROC difference in 340-case MRMC prostate MRI study.
Tested version: Prostate MR AI (VA10A) configuration described in K241770Case-level sensitivity at threshold >=3 in Fully inclusive MRMC prostate MRI analysis.
Tested version: Prostate MR AI (VA10A) configuration described in K241770Case-level specificity at threshold >=3 in Fully inclusive MRMC prostate MRI analysis.
Tested version: Prostate MR AI (VA10A) configuration described in K241770FDA 510(k) standalone performance and multi-reader multi-case reader study for prostate MRI interpretation support. · 340 prostate MRI cases read by 12 ABR radiologists at two U.S. sites, with separate radiology-ground-truth and biopsy-ground-truth cohorts.
exact submission · Tested version: Prostate MR AI (VA10A) configuration described in K241770 · n=340 · 2 sites · Sponsor or vendor studyK241770
The FDA material reports reader-level and case-level endpoints; values are tied to the stated version, population, protocol, and reader study.
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 configuration was found. Obtain a written quote separating hardware or license basis, implementation, interfaces, infrastructure, training, service, upgrades, renewal, consumables, and exit costs.
No separate named-product payment identified in reviewed public 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.
Exact-identifier review does not prove absence of all product-family safety signals.
Buyer worksheet
Research record
This audit distinguishes completed source review from fields that have not yet been researched.
The discovery snapshot contains no PubMed or ClinicalTrials.gov candidates for K241770; no external evidence was promoted. The current discovery snapshot contains 0 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, 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
Quantib B.V.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
Quibim S.L.
FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...
JLK Inc.
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
Quantib BV
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.