510(k) K250119
K250119 is an FDA 510(k) premarket notification submitted by Tempus AI, Inc. for the device "Tempus ECG-Low EF". The FDA issued a decision of Substantially Equivalent on July 15, 2025. The device falls under product code QYE (Reduced Ejection Fraction Machine Learning-Based Notification Software), a Class II device regulated under 21 CFR 870.2380. Tempus AI, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 2025
- Date Received
- January 16, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reduced Ejection Fraction Machine Learning-Based Notification Software
- Device Class
- Class II
- Regulation Number
- 870.2380
- Review Panel
- CV
- Submission Type
Reduced Ejection Fraction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a reduced ejection fraction for further referral or diagnostic follow-up.