FDA 510(k)

Tempus Pixel

K号: K252539 · 2025-09-03

决定日期2025-09-03

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Tempus Pixel is the device name listed in this FDA 510(k) record. The listed applicant is Arterys, Inc.. It received FDA 510(k) clearance on 2025-09-03 under 510(k) number K252539. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tempus Pixel?

Tempus Pixel is a medical device that received FDA 510(k) clearance on 2025-09-03. The listed applicant is Arterys, Inc.. The 510(k) number is K252539.

When did Tempus Pixel receive FDA 510(k) clearance?

Tempus Pixel received FDA 510(k) clearance on 2025-09-03, under 510(k) number K252539.

Who is the listed applicant for Tempus Pixel?

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

What is the FDA product code for Tempus Pixel?

The FDA product code for Tempus Pixel is QIH.

列明Arterys, 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。

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