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FDA 510(k)

SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO

K-Number: K192061 · 2019-11-21

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2019-11-21
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2019-11-21 under 510(k) number K192061. 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 Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO?

SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO is a medical device that received FDA 510(k) clearance on 2019-11-21. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K192061.

When did SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO receive FDA 510(k) clearance?

SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO received FDA 510(k) clearance on 2019-11-21, under 510(k) number K192061.

Who is the listed applicant for SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO?

The FDA product code for SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO 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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