FDA 510(k)

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

K-Number: K242258 · 2024-11-26

Decision Date2024-11-26

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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

When was MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) approved by the FDA?

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

What company makes MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)?

MROpen Evo (03-2000-00); MROpen Evo (03-4000-00) is manufactured by Asg Superconductors S.P.A..

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 Devices by Asg Superconductors S.P.A.

K193116MRopen EVO K192690Upgrade Kit MR GUI PRO, MrJ 3300 Plus K190524MRopen 0.5 T

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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.