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FDA 510(k)

MAGNETOM Avantofit, MAGNETOM Skyrafit

K-Number: K162102 · 2016-11-22

ApplicantSiemens Medi Cal Solutions, Inc.
Decision Date2016-11-22
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM Avantofit, MAGNETOM Skyrafit is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K162102. 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 Avantofit, MAGNETOM Skyrafit?

MAGNETOM Avantofit, MAGNETOM Skyrafit is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K162102.

When did MAGNETOM Avantofit, MAGNETOM Skyrafit receive FDA 510(k) clearance?

MAGNETOM Avantofit, MAGNETOM Skyrafit received FDA 510(k) clearance on 2016-11-22, under 510(k) number K162102.

Who is the listed applicant for MAGNETOM Avantofit, MAGNETOM Skyrafit?

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

What is the FDA product code for MAGNETOM Avantofit, MAGNETOM Skyrafit?

The FDA product code for MAGNETOM Avantofit, MAGNETOM Skyrafit 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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