FDA 510(k)

MRCP+ 版本 2 (MRCP+ v2)

K号: K233930 · 2024-03-13

决定日期2024-03-13

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

MRCP+ version 2 (MRCP+ v2) is the device name listed in this FDA 510(k) record. The listed applicant is Perspectum. It received FDA 510(k) clearance on 2024-03-13 under 510(k) number K233930. 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 MRCP+ version 2 (MRCP+ v2)?

MRCP+ version 2 (MRCP+ v2) is a medical device that received FDA 510(k) clearance on 2024-03-13. The listed applicant is Perspectum. The 510(k) number is K233930.

When did MRCP+ version 2 (MRCP+ v2) receive FDA 510(k) clearance?

MRCP+ version 2 (MRCP+ v2) received FDA 510(k) clearance on 2024-03-13, under 510(k) number K233930.

Who is the listed applicant for MRCP+ version 2 (MRCP+ v2)?

The FDA 510(k) record lists Perspectum as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRCP+ version 2 (MRCP+ v2)?

The FDA product code for MRCP+ version 2 (MRCP+ v2) is LLZ.

列明Perspectum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。

K230294CoverScan（CoverScan v1.1）K213960LiverMultiScan v5 (LMSv5)

官方来源

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