BIOGRAPH One
K-Number: K253023 · 2026-01-15
ApplicantSiemens Healthineers AG
Decision Date2026-01-15
Product CodeOUO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
BIOGRAPH One is a medical device manufactured by Siemens Healthineers AG. It received FDA 510(k) clearance on 2026-01-15 under approval number K253023. The device is classified under product code OUO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BIOGRAPH One?
BIOGRAPH One is a medical device that received FDA 510(k) clearance on 2026-01-15. It is manufactured by Siemens Healthineers AG. The 510(k) number is K253023.
When was BIOGRAPH One approved by the FDA?
BIOGRAPH One received FDA 510(k) clearance on 2026-01-15, under approval number K253023.
What company makes BIOGRAPH One?
BIOGRAPH One is manufactured by Siemens Healthineers AG.
What is the FDA product code for BIOGRAPH One?
The FDA product code for BIOGRAPH One is OUO.
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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.