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Tempus AI, Inc.

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories4
Latest FDA decision2026-05-28
TypeNumberDevice NameCodeDateActions
PMA P210011 Next generation sequencing oncology panel, somatic or germline variant detection systemPQP2026-05-28 View
510(k) K241868 xR IVDPZM2025-09-19 View
510(k) K250119 Tempus ECG-Low EFQYE2025-07-15 View
510(k) K233549 Tempus ECG-AFSBQ2024-06-21 View

Related Clinical Trials

NCT06911632Multi-site Study of the Clinical Impact of an AI-assisted Approach to Referring Patients With Interstitial Lung Disease for Diagnostic Evaluation of Pulmonary HypertensionRECRUITINGNCT06511505NOrthwestern Tempus AI-enaBLed Electrocardiography (NOTABLE) TrialRECRUITING
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