Prostate MR AI (VA10A)— 510(k) K241770

Substantially Equivalent

Siemens Healthcare GmbH

FDA 510(k) clearance K241770 for Prostate MR AI (VA10A), Substantially Equivalent on 2025-03-05. Applicant: Siemens Healthcare GmbH. Device class: 2.

Clearance details

Applicant
Siemens Healthcare GmbH
Product code
Code QDQ
Device class
Class 2
Regulation
21 CFR 892.2090
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Erlanger, DE
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