Tempus Pixel— 510(k) K252539

Substantially Equivalent

Arterys, Inc.

FDA 510(k) clearance K252539 for Tempus Pixel, Substantially Equivalent on 2025-09-03. Applicant: Arterys, Inc.. Device class: 2.

Clearance details

Applicant: Arterys, Inc.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-08-12
Decision date: 2025-09-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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