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FDA 510(k)

Scenium VE20 Software

K-Number: K173597 · 2018-04-04

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2018-04-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Scenium VE20 Software 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 2018-04-04 under 510(k) number K173597. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Scenium VE20 Software?

Scenium VE20 Software is a medical device that received FDA 510(k) clearance on 2018-04-04. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K173597.

When did Scenium VE20 Software receive FDA 510(k) clearance?

Scenium VE20 Software received FDA 510(k) clearance on 2018-04-04, under 510(k) number K173597.

Who is the listed applicant for Scenium VE20 Software?

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 Scenium VE20 Software?

The FDA product code for Scenium VE20 Software is LLZ.

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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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