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FDA 510(k)

NAEOTOM Alpha

K-Number: K233657 · 2024-03-28

Decision Date2024-03-28
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NAEOTOM Alpha is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2024-03-28 under approval number K233657. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAEOTOM Alpha?

NAEOTOM Alpha is a medical device that received FDA 510(k) clearance on 2024-03-28. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K233657.

When was NAEOTOM Alpha approved by the FDA?

NAEOTOM Alpha received FDA 510(k) clearance on 2024-03-28, under approval number K233657.

What company makes NAEOTOM Alpha?

NAEOTOM Alpha is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for NAEOTOM Alpha?

The FDA product code for NAEOTOM Alpha is JAK.

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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.