510(k) clearance
Tempus ECG-MR
- 510(k) number
- K254297
- Applicant
- Tempus AI, Inc.
- Decision date
- Sep 25, 2026
- Date received
- Dec 31, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- SBQ
- Device type
- Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
- Device class
- Class II
- Regulation
- 21 CFR 870.2380
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Chicago, IL, US