Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
Atrial fibrillation risk prediction machine learning-based notification software is a cardiovascular software device that employs machine learning techniques to suggest the likelihood of a future occurrence of atrial fibrillation, intended to prompt further referral or diagnostic follow-up rather than to provide a definitive diagnosis. It is classified as FDA Class II (510(k) required) under regulation 870.2380 in the Cardiovascular specialty, with product code SBQ. The device is not an implant and does not support life-sustaining functions.
Research product code SBQ in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- SBQ
- Device Class
- FDA class 2
- Regulation Number
- 870.2380
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
Atrial Fibrillation Risk Prediction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a future occurrence of atrial fibrillation for further referral or diagnostic follow-up.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233549 | Tempus ECG-AF | Jun 21, 2024 | Substantially Equivalent | Tempus AI, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.