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FDA 510(k)

SOMATOM Edge Plus

K-Number: K173607 · 2018-03-21

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2018-03-21
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOMATOM Edge Plus 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 2018-03-21 under 510(k) number K173607. 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 Edge Plus?

SOMATOM Edge Plus is a medical device that received FDA 510(k) clearance on 2018-03-21. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K173607.

When did SOMATOM Edge Plus receive FDA 510(k) clearance?

SOMATOM Edge Plus received FDA 510(k) clearance on 2018-03-21, under 510(k) number K173607.

Who is the listed applicant for SOMATOM Edge Plus?

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 Edge Plus?

The FDA product code for SOMATOM Edge Plus 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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