Class Class II

xR IVD (K241868)

K241868 2025-09-19 Traditional
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Description

xR IVD by Tempus AI, Inc. — FDA 510(k) cleared pathology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK241868
Clearance Date2025-09-19
Clearance TypeTraditional
Product CodePZM
Regulation Number866.6080

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