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FDA 510(k)

MRopen EVO

K-Number: K193116 · 2019-12-20

ApplicantAsg Superconductors S.P.A.
Decision Date2019-12-20
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRopen EVO is the device name listed in this FDA 510(k) record. The listed applicant is Asg Superconductors S.P.A.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K193116. 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 MRopen EVO?

MRopen EVO is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Asg Superconductors S.P.A.. The 510(k) number is K193116.

When did MRopen EVO receive FDA 510(k) clearance?

MRopen EVO received FDA 510(k) clearance on 2019-12-20, under 510(k) number K193116.

Who is the listed applicant for MRopen EVO?

The FDA 510(k) record lists Asg Superconductors S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRopen EVO?

The FDA product code for MRopen EVO is LNH.

Other records listing Asg Superconductors S.P.A. 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.

K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)K192690Upgrade Kit MR GUI PRO, MrJ 3300 PlusK190524MRopen 0.5 T

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.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

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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