Biograph Vision.X and Biograph Vision.X Edge
K-Number: K231833 · 2023-07-13
ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2023-07-13
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Biograph Vision.X and Biograph Vision.X Edge is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2023-07-13 under approval number K231833. 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.X and Biograph Vision.X Edge?
Biograph Vision.X and Biograph Vision.X Edge is a medical device that received FDA 510(k) clearance on 2023-07-13. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K231833.
When was Biograph Vision.X and Biograph Vision.X Edge approved by the FDA?
Biograph Vision.X and Biograph Vision.X Edge received FDA 510(k) clearance on 2023-07-13, under approval number K231833.
What company makes Biograph Vision.X and Biograph Vision.X Edge?
Biograph Vision.X and Biograph Vision.X Edge is manufactured by Siemens Medical Solutions USA, Inc..
What is the FDA product code for Biograph Vision.X and Biograph Vision.X Edge?
The FDA product code for Biograph Vision.X and Biograph Vision.X Edge 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.