FDA 510(k)

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

K号: K242258 · 2024-11-26

决定日期2024-11-26

产品代码LNH

咨询委员会RA

决定实质等同

器械摘要

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.

常见问题

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.

列明Asg Superconductors S.P.A.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K193116MRopen EVO K192690升级套件 MR GUI PRO，MrJ 3300 Plus K190524MRopen 0.5 T

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。