FDA 510(k)

Tempus Pixel

K-Number: K252539 · 2025-09-03

Decision Date2025-09-03

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Arterys, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203744Arterys MICA K192437Arterys MICA K182034Arterys MICA K173542Arterys Oncology DL K171544Arterys Viewer K163253Arterys Cardio DL

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.