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FDA 510(k)

xR IVD

K-Number: K241868 · 2025-09-19

ApplicantTempus AI, Inc.
Decision Date2025-09-19
Product CodePZM
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

xR IVD is a medical device manufactured by Tempus AI, Inc.. It received FDA 510(k) clearance on 2025-09-19 under approval number K241868. The device is classified under product code PZM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the xR IVD?

xR IVD is a medical device that received FDA 510(k) clearance on 2025-09-19. It is manufactured by Tempus AI, Inc.. The 510(k) number is K241868.

When was xR IVD approved by the FDA?

xR IVD received FDA 510(k) clearance on 2025-09-19, under approval number K241868.

What company makes xR IVD?

xR IVD is manufactured by Tempus AI, Inc..

What is the FDA product code for xR IVD?

The FDA product code for xR IVD is PZM.

Other Devices by Tempus AI, Inc.

K233549Tempus ECG-AF K250119Tempus ECG-Low EF

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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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