FDA 510(k)

CMN 毛细血管功能与虚拟专家用于 MRI、CT 和 CBCT

K号: K253831 · 2026-05-18

决定日期2026-05-18

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT is the device name listed in this FDA 510(k) record. The listed applicant is Cercare Medical A/S. It received FDA 510(k) clearance on 2026-05-18 under 510(k) number K253831. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CMN Capillary Function with Virtual Expert for MRI, CT and CBCT?

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT is a medical device that received FDA 510(k) clearance on 2026-05-18. The listed applicant is Cercare Medical A/S. The 510(k) number is K253831.

When did CMN Capillary Function with Virtual Expert for MRI, CT and CBCT receive FDA 510(k) clearance?

CMN Capillary Function with Virtual Expert for MRI, CT and CBCT received FDA 510(k) clearance on 2026-05-18, under 510(k) number K253831.

Who is the listed applicant for CMN Capillary Function with Virtual Expert for MRI, CT and CBCT?

The FDA 510(k) record lists Cercare Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CMN Capillary Function with Virtual Expert for MRI, CT and CBCT?

The FDA product code for CMN Capillary Function with Virtual Expert for MRI, CT and CBCT is LLZ.

列明Cercare Medical A/S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。

K260316CMN 毛细血管功能与肿瘤学虚拟专家 K241989Cercare 医疗神经套件（CMN）毛细血管功能与虚拟专家 K230016Cercare 医疗神经套件

官方来源

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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。