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FDA 510(k)

MeVis Liver Suite

K-Number: K232045 · 2023-10-27

ApplicantMeVis Medical Solutions AG
Decision Date2023-10-27
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MeVis Liver Suite is the device name listed in this FDA 510(k) record. The listed applicant is MeVis Medical Solutions AG. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K232045. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MeVis Liver Suite?

MeVis Liver Suite is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is MeVis Medical Solutions AG. The 510(k) number is K232045.

When did MeVis Liver Suite receive FDA 510(k) clearance?

MeVis Liver Suite received FDA 510(k) clearance on 2023-10-27, under 510(k) number K232045.

Who is the listed applicant for MeVis Liver Suite?

The FDA 510(k) record lists MeVis Medical Solutions AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MeVis Liver Suite?

The FDA product code for MeVis Liver Suite is JAK.

Other records listing MeVis Medical Solutions AG as applicant

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.

K260576MeVis AVM ContourK201501Veolity

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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