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FDA 510(k)

Tempus Pixel

K-Number: K252539 · 2025-09-03

ApplicantArterys, Inc.
Decision Date2025-09-03
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Tempus Pixel is a medical device manufactured by Arterys, Inc.. It received FDA 510(k) clearance on 2025-09-03 under approval 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. It is manufactured by Arterys, Inc.. The 510(k) number is K252539.

When was Tempus Pixel approved by the FDA?

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

What company makes Tempus Pixel?

Tempus Pixel is manufactured by Arterys, Inc..

What is the FDA product code for Tempus Pixel?

The FDA product code for Tempus Pixel is QIH.

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Official Source

View on FDA Database →

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

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