Biograph Horizon
K-Number: K193178 · 2020-02-12
ApplicantSiemens Medical Solution USA, Inc.
Decision Date2020-02-12
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Biograph Horizon is a medical device manufactured by Siemens Medical Solution USA, Inc.. It received FDA 510(k) clearance on 2020-02-12 under approval number K193178. 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 Horizon?
Biograph Horizon is a medical device that received FDA 510(k) clearance on 2020-02-12. It is manufactured by Siemens Medical Solution USA, Inc.. The 510(k) number is K193178.
When was Biograph Horizon approved by the FDA?
Biograph Horizon received FDA 510(k) clearance on 2020-02-12, under approval number K193178.
What company makes Biograph Horizon?
Biograph Horizon is manufactured by Siemens Medical Solution USA, Inc..
What is the FDA product code for Biograph Horizon?
The FDA product code for Biograph Horizon 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.