FDA 510(k)

Upgrade Kit MR GUI PRO, MrJ 3300 Plus

K-Number: K192690 · 2019-10-24

Decision Date2019-10-24

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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

When was Upgrade Kit MR GUI PRO, MrJ 3300 Plus approved by the FDA?

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

What company makes Upgrade Kit MR GUI PRO, MrJ 3300 Plus?

Upgrade Kit MR GUI PRO, MrJ 3300 Plus is manufactured by Asg Superconductors S.P.A..

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 Devices by Asg Superconductors S.P.A.

K193116MRopen EVO K190524MRopen 0.5 T K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)

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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.