xR IVD— 510(k) K241868

Substantially Equivalent

Tempus AI, Inc.

FDA 510(k) clearance K241868 for xR IVD, Substantially Equivalent on 2025-09-19. Applicant: Tempus AI, Inc.. Device class: 2.

Clearance details

Applicant: Tempus AI, Inc.
Product code: Code PZM
Device class: Class 2
Regulation: 21 CFR 866.6080
Advisory panel: Pathology
Date received: 2024-06-27
Decision date: 2025-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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