Biograph Vision
K-Number: K180811 · 2018-05-23
ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2018-05-23
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Biograph Vision is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2018-05-23 under approval number K180811. 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 Vision?
Biograph Vision is a medical device that received FDA 510(k) clearance on 2018-05-23. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K180811.
When was Biograph Vision approved by the FDA?
Biograph Vision received FDA 510(k) clearance on 2018-05-23, under approval number K180811.
What company makes Biograph Vision?
Biograph Vision is manufactured by Siemens Medical Solutions USA, Inc..
What is the FDA product code for Biograph Vision?
The FDA product code for Biograph Vision 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.