Cleared Special

Biograph Trinion

K251561 · Siemens Medical Solutions USA, Inc. · Radiology
Jul 2025
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K251561 is an FDA 510(k) clearance for the Biograph Trinion, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Siemens Medical Solutions USA, Inc. (Knoxville, US). The FDA issued a Cleared decision on July 31, 2025, 71 days after receiving the submission on May 21, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K251561 FDA.gov
FDA Decision Cleared SESE
Date Received May 21, 2025
Decision Date July 31, 2025
Days to Decision 71 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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