Biograph Trinion
K-Number: K251561 · 2025-07-31
ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2025-07-31
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Biograph Trinion is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2025-07-31 under approval number K251561. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Biograph Trinion?
Biograph Trinion is a medical device that received FDA 510(k) clearance on 2025-07-31. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K251561.
When was Biograph Trinion approved by the FDA?
Biograph Trinion received FDA 510(k) clearance on 2025-07-31, under approval number K251561.
What company makes Biograph Trinion?
Biograph Trinion is manufactured by Siemens Medical Solutions USA, Inc..
What is the FDA product code for Biograph Trinion?
The FDA product code for Biograph Trinion is KPS.
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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.