510(k) DEN230003
DEN230003 is an FDA 510(k) premarket notification submitted by Viz. Ai, Inc. for the device "Viz HCM". The FDA issued a decision of De Novo Granted on August 3, 2023. The device falls under product code QXO (Cardiovascular Machine Learning-Based Notification Software), a Class II device regulated under 21 CFR 870.2380. Viz. Ai, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 3, 2023
- Date Received
- January 10, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cardiovascular Machine Learning-Based Notification Software
- Device Class
- Class II
- Regulation Number
- 870.2380
- Review Panel
- CV
- Submission Type
Cardiovascular machine learning-based notification software employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up. The software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care. It is intended as the basis for further testing and is not intended to provide diagnostic quality output. It is not intended to identify or detect arrhythmias.