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FDA 510(k)

NAEOTOM Alpha, Scan&GO

K-Number: K211591 · 2021-09-30

Decision Date2021-09-30
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NAEOTOM Alpha, Scan&GO is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2021-09-30 under approval number K211591. 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, Scan&GO?

NAEOTOM Alpha, Scan&GO is a medical device that received FDA 510(k) clearance on 2021-09-30. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K211591.

When was NAEOTOM Alpha, Scan&GO approved by the FDA?

NAEOTOM Alpha, Scan&GO received FDA 510(k) clearance on 2021-09-30, under approval number K211591.

What company makes NAEOTOM Alpha, Scan&GO?

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

What is the FDA product code for NAEOTOM Alpha, Scan&GO?

The FDA product code for NAEOTOM Alpha, Scan&GO 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.