FDA 510(k)

HeartSee 心脏 P.E.T. 处理软件 - HeartSee 版本 4 的可选屏幕显示

K号: K231731 · 2023-08-21

决定日期2023-08-21

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 is the device name listed in this FDA 510(k) record. The listed applicant is Mcgovern Medical School. It received FDA 510(k) clearance on 2023-08-21 under 510(k) number K231731. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4?

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 is a medical device that received FDA 510(k) clearance on 2023-08-21. The listed applicant is Mcgovern Medical School. The 510(k) number is K231731.

When did Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 receive FDA 510(k) clearance?

Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 received FDA 510(k) clearance on 2023-08-21, under 510(k) number K231731.

Who is the listed applicant for Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4?

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

What is the FDA product code for Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4?

The FDA product code for Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 is KPS.

列明Mcgovern Medical School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。

K202679HeartSee 心脏 P.E.T. 处理软件 - HeartSee 版本 3 的可选屏幕显示

相关器械（代码：KPS）

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。

官方来源

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