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FDA 510(k)

Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT

K-Number: K162736 · 2016-10-25

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2016-10-25
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2016-10-25 under approval number K162736. 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 and Biograph mCT PET/CT and Biograph mCT Flow PET/CT?

Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT is a medical device that received FDA 510(k) clearance on 2016-10-25. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K162736.

When was Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT approved by the FDA?

Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT received FDA 510(k) clearance on 2016-10-25, under approval number K162736.

What company makes Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT?

Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT?

The FDA product code for Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT 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.

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