Coronary Artery Disease Machine Learning-Based Notification Software
The coronary artery disease machine learning-based notification software (product code QXX) is a Class 2 Cardiovascular device (regulation 870.2380) that employs machine learning techniques to suggest the likelihood of coronary artery disease for further referral or diagnostic follow-up. Requiring 510(k) clearance, the software provides notification output intended as the basis for further evaluation and is not intended as a standalone diagnostic tool. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QXX
- Device Class
- FDA class 2
- Regulation Number
- 870.2380
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
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 |
|---|---|---|---|---|
| K232686 | CorVista® System | Sep 08, 2023 | Substantially Equivalent | Corvista Health, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.