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FDA 510(k)

MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)

K-Number: K242258 · 2024-11-26

ApplicantAsg Superconductors S.P.A.
Decision Date2024-11-26
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) 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 2024-11-26 under 510(k) number K242258. 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 (03-2000-00); MROpen Evo (03-4000-00)?

MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Asg Superconductors S.P.A.. The 510(k) number is K242258.

When did MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) receive FDA 510(k) clearance?

MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) received FDA 510(k) clearance on 2024-11-26, under 510(k) number K242258.

Who is the listed applicant for MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)?

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 (03-2000-00); MROpen Evo (03-4000-00)?

The FDA product code for MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) 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.

K193116MRopen EVOK192690Upgrade 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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