K232686 is an FDA 510(k) clearance for the CorVista® System. This device is classified as a Coronary Artery Disease Machine Learning-based Notification Software (Class II - Special Controls, product code QXX).
Submitted by Corvista Health, Inc. (Washington, US). The FDA issued a Cleared decision on September 8, 2023, 7 days after receiving the submission on September 1, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2380. 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) Number | K232686 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2023 |
| Decision Date | September 08, 2023 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QXX - Coronary Artery Disease Machine Learning-based Notification Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2380 |
| 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. |