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FDA 510(k)

MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D

K-Number: K181613 · 2018-11-06

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2018-11-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D 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 2018-11-06 under 510(k) number K181613. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D?

MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D is a medical device that received FDA 510(k) clearance on 2018-11-06. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K181613.

When did MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D receive FDA 510(k) clearance?

MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D received FDA 510(k) clearance on 2018-11-06, under 510(k) number K181613.

Who is the listed applicant for MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D?

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 MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D?

The FDA product code for MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D is LNH.

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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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