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FDA 510(k)

SOMATOM On.site and On.scene

K-Number: K193277 · 2020-07-22

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2020-07-22
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMATOM On.site and On.scene is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2020-07-22 under approval number K193277. 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 and On.scene?

SOMATOM On.site and On.scene is a medical device that received FDA 510(k) clearance on 2020-07-22. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K193277.

When was SOMATOM On.site and On.scene approved by the FDA?

SOMATOM On.site and On.scene received FDA 510(k) clearance on 2020-07-22, under approval number K193277.

What company makes SOMATOM On.site and On.scene?

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

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

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

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Official Source

View on FDA Database →

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

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