Cleared Special

Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems

K251671 · Siemens Medical Solutions USA, Inc. · Radiology
Jul 2025
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K251671 is an FDA 510(k) clearance for the Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Siemens Medical Solutions USA, Inc. (Hiffman Estates, US). The FDA issued a Cleared decision on July 3, 2025, 34 days after receiving the submission on May 30, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K251671 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2025
Decision Date July 03, 2025
Days to Decision 34 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPS — System, Tomography, Computed, Emission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1200

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