Cleared Traditional

AI-Rad Companion Prostate MR

K252608 · Siemens Healthcare GmbH · Radiology
Sep 2025
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K252608 is an FDA 510(k) clearance for the AI-Rad Companion Prostate MR, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Siemens Healthcare GmbH (Erlanger, DE). The FDA issued a Cleared decision on September 9, 2025, 22 days after receiving the submission on August 18, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K252608 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2025
Decision Date September 09, 2025
Days to Decision 22 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050

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