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FDA 510(k)

Prostate MR AI (VA10A)

K-Number: K241770 · 2025-03-05

ApplicantSiemens Healthcare GmbH
Decision Date2025-03-05
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Prostate MR AI (VA10A) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare GmbH. It received FDA 510(k) clearance on 2025-03-05 under 510(k) number K241770. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prostate MR AI (VA10A)?

Prostate MR AI (VA10A) is a medical device that received FDA 510(k) clearance on 2025-03-05. The listed applicant is Siemens Healthcare GmbH. The 510(k) number is K241770.

When did Prostate MR AI (VA10A) receive FDA 510(k) clearance?

Prostate MR AI (VA10A) received FDA 510(k) clearance on 2025-03-05, under 510(k) number K241770.

Who is the listed applicant for Prostate MR AI (VA10A)?

The FDA 510(k) record lists Siemens Healthcare GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prostate MR AI (VA10A)?

The FDA product code for Prostate MR AI (VA10A) is QDQ.

Other records listing Siemens Healthcare GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253264myAblation Guide (VC10A)K253689syngo Dynamics (VA41F)K252548AI-Rad Companion Organs RTK253057AI-Rad Companion Brain MRK252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.RiseK252608AI-Rad Companion Prostate MR

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Related Devices (Code: QDQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260898Transpara (2.1.0)Screenpoint Medical B.V.K260086CadAI-B DxBeamWorks, Inc.K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.K260714MammoScreen® (5)TherapixelK253825Saige-DxDeepHealth, Inc.K253682DeepHealth ProstateAIQuantib B.V.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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