K233666 is an FDA 510(k) clearance for the CorVista System with PH Add-On. This device is classified as a Pulmonary Hypertension Machine Learning-based Notification Software (Class II - Special Controls, product code SAT).
Submitted by Analytics For Life, Inc. (Toronto, CA). The FDA issued a Cleared decision on April 5, 2024, 142 days after receiving the submission on November 15, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2380. Pulmonary Hypertension Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of Pulmonary Hypertension For Further Referral Or Diagnostic Follow-up..
| 510(k) Number | K233666 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2023 |
| Decision Date | April 05, 2024 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | SAT - Pulmonary Hypertension Machine Learning-based Notification Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2380 |
| Definition | Pulmonary Hypertension Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of Pulmonary Hypertension For Further Referral Or Diagnostic Follow-up. |