510(k) K233666
K233666 is an FDA 510(k) premarket notification submitted by Analytics For Life, Inc. for the device "CorVista System with PH Add-On". The FDA issued a decision of Substantially Equivalent on April 5, 2024. The device falls under product code SAT (Pulmonary Hypertension Machine Learning-Based Notification Software), a Class II device regulated under 21 CFR 870.2380.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2024
- Date Received
- November 15, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pulmonary Hypertension Machine Learning-Based Notification Software
- Device Class
- Class II
- Regulation Number
- 870.2380
- Review Panel
- CV
- Submission Type
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.