Biograph Horizon PET/CT
K-Number: K170904 · 2017-06-01
ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2017-06-01
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Biograph Horizon PET/CT is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2017-06-01 under approval number K170904. 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 PET/CT?
Biograph Horizon PET/CT is a medical device that received FDA 510(k) clearance on 2017-06-01. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K170904.
When was Biograph Horizon PET/CT approved by the FDA?
Biograph Horizon PET/CT received FDA 510(k) clearance on 2017-06-01, under approval number K170904.
What company makes Biograph Horizon PET/CT?
Biograph Horizon PET/CT is manufactured by Siemens Medical Solutions USA, Inc..
What is the FDA product code for Biograph Horizon PET/CT?
The FDA product code for Biograph Horizon PET/CT is KPS.
Other Devices by Siemens Medical Solutions USA, Inc.
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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.