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FDA 510(k)

MAGNETOM ESSENZA

K-Number: K161795 · 2016-11-18

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2016-11-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM ESSENZA 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 2016-11-18 under 510(k) number K161795. 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 ESSENZA?

MAGNETOM ESSENZA is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K161795.

When did MAGNETOM ESSENZA receive FDA 510(k) clearance?

MAGNETOM ESSENZA received FDA 510(k) clearance on 2016-11-18, under 510(k) number K161795.

Who is the listed applicant for MAGNETOM ESSENZA?

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 ESSENZA?

The FDA product code for MAGNETOM ESSENZA is LNH.

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Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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