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FDA 510(k)

MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea

K-Number: K203443 · 2021-03-31

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2021-03-31
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea 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 2021-03-31 under 510(k) number K203443. 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 Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea?

MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea is a medical device that received FDA 510(k) clearance on 2021-03-31. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K203443.

When did MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea receive FDA 510(k) clearance?

MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea received FDA 510(k) clearance on 2021-03-31, under 510(k) number K203443.

Who is the listed applicant for MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea?

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 Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea?

The FDA product code for MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea 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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