QXX — Coronary Artery Disease Machine Learning-Based Notification Software Class II
FDA product code QXX covers "Coronary Artery Disease Machine Learning-Based Notification Software", a Class II medical device regulated under 21 CFR 870.2380. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QXX
- Device Class
- Class II
- Regulation Number
- 870.2380
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Coronary Artery Disease machine learning-based notification software employs machine learning techniques to suggest the likelihood of coronary artery disease for further referral or diagnostic follow-up.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232686 | corvista health | CorVista® System | September 8, 2023 |