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FDA 510(k)

SOMATOM X.cite

K-Number: K191891 · 2019-11-06

Decision Date2019-11-06
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMATOM X.cite is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2019-11-06 under approval number K191891. 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 SOMATOM X.cite?

SOMATOM X.cite is a medical device that received FDA 510(k) clearance on 2019-11-06. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K191891.

When was SOMATOM X.cite approved by the FDA?

SOMATOM X.cite received FDA 510(k) clearance on 2019-11-06, under approval number K191891.

What company makes SOMATOM X.cite?

SOMATOM X.cite is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for SOMATOM X.cite?

The FDA product code for SOMATOM X.cite is JAK.

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Official Source

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