Device |
atrial fibrillation risk prediction machine learning-based notification software |
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. |
Physical State |
Consists of one or more non-invasive physiological inputs, a machine learning based for disease detection or classification, and an output on the presence, absence, or likelihood of a future occurrence of atrial fibrillation. |
Technical Method |
non-invasive physiological measurement(s) |
Target Area |
Cardiovascular |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | SBQ |
Premarket Review |
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
Submission Type |
510(k)
|
Regulation Number |
870.2380
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|