FDA 510(k)

SubtlePET

K号: K211964 · 2021-09-28

决定日期2021-09-28

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

SubtlePET is the device name listed in this FDA 510(k) record. The listed applicant is Subtle Medical, Inc.. It received FDA 510(k) clearance on 2021-09-28 under 510(k) number K211964. 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 SubtlePET?

SubtlePET is a medical device that received FDA 510(k) clearance on 2021-09-28. The listed applicant is Subtle Medical, Inc.. The 510(k) number is K211964.

When did SubtlePET receive FDA 510(k) clearance?

SubtlePET received FDA 510(k) clearance on 2021-09-28, under 510(k) number K211964.

Who is the listed applicant for SubtlePET?

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

What is the FDA product code for SubtlePET?

The FDA product code for SubtlePET is KPS.

列明Subtle Medical, Inc.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。

K254120SubtleHD-CT (1.x)K254013SubtleHD-PET (1.x)K243250SubtleHD (1.x)K240290AiMIFY (1.x)K241329SubtleSYNTH (1.x)K233699SubtleREFORMAT (1.x)

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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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