BIOGRAPH One
K-Number: K253023 · 2026-01-15
Device Summary
Frequently Asked Questions
What is the BIOGRAPH One?
BIOGRAPH One is a medical device that received FDA 510(k) clearance on 2026-01-15. The listed applicant is Siemens Healthineers AG. The 510(k) number is K253023.
When did BIOGRAPH One receive FDA 510(k) clearance?
BIOGRAPH One received FDA 510(k) clearance on 2026-01-15, under 510(k) number K253023.
Who is the listed applicant for BIOGRAPH One?
The FDA 510(k) record lists Siemens Healthineers AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BIOGRAPH One?
The FDA product code for BIOGRAPH One is OUO.
Other records listing Siemens Healthineers AG as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: OUO)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.