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FDA 510(k)

SOMATOM On.site

K-Number: K241295 · 2024-09-03

Decision Date2024-09-03
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMATOM On.site is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2024-09-03 under approval number K241295. 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 On.site?

SOMATOM On.site is a medical device that received FDA 510(k) clearance on 2024-09-03. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K241295.

When was SOMATOM On.site approved by the FDA?

SOMATOM On.site received FDA 510(k) clearance on 2024-09-03, under approval number K241295.

What company makes SOMATOM On.site?

SOMATOM On.site is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for SOMATOM On.site?

The FDA product code for SOMATOM On.site is JAK.

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Official Source

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