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FDA 510(k)

Biograph VK10

K-Number: K233677 · 2024-01-12

Decision Date2024-01-12
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Biograph VK10 is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2024-01-12 under approval number K233677. 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 VK10?

Biograph VK10 is a medical device that received FDA 510(k) clearance on 2024-01-12. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K233677.

When was Biograph VK10 approved by the FDA?

Biograph VK10 received FDA 510(k) clearance on 2024-01-12, under approval number K233677.

What company makes Biograph VK10?

Biograph VK10 is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for Biograph VK10?

The FDA product code for Biograph VK10 is KPS.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.