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FDA 510(k)

Upgrade Kit MR GUI PRO, MrJ 3300 Plus

K-Number: K192690 · 2019-10-24

ApplicantAsg Superconductors S.P.A.
Decision Date2019-10-24
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Upgrade Kit MR GUI PRO, MrJ 3300 Plus 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 2019-10-24 under 510(k) number K192690. 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 Upgrade Kit MR GUI PRO, MrJ 3300 Plus?

Upgrade Kit MR GUI PRO, MrJ 3300 Plus is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Asg Superconductors S.P.A.. The 510(k) number is K192690.

When did Upgrade Kit MR GUI PRO, MrJ 3300 Plus receive FDA 510(k) clearance?

Upgrade Kit MR GUI PRO, MrJ 3300 Plus received FDA 510(k) clearance on 2019-10-24, under 510(k) number K192690.

Who is the listed applicant for Upgrade Kit MR GUI PRO, MrJ 3300 Plus?

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 Upgrade Kit MR GUI PRO, MrJ 3300 Plus?

The FDA product code for Upgrade Kit MR GUI PRO, MrJ 3300 Plus 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)K193116MRopen EVOK190524MRopen 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

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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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