Viz HCM is an AI-enabled medical device from Viz.ai, Inc. that the U.S. FDA granted through De Novo DEN230003 on August 3, 2023. Its lead review panel is Cardiovascular and its primary product code is QXO (Cardiovascular Machine Learning-Based Notification Software).
See also FDA-cleared AI cardiovascular devices in 2023, all FDA AI clearances in 2023, top cardiovascular AI devices.
Key facts
| Submission number | DEN230003 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Viz.ai, Inc. |
| Lead review panel | Cardiovascular |
| Primary product code | QXO — Cardiovascular Machine Learning-Based Notification Software |
| Applicant (openFDA) | Viz. Ai, Inc. |
| Applicant location | San Francisco, CA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 870.2380 |
| Decision code | DENG |
| Submission type | Direct |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. Viz HCM went through this pathway (DEN230003).
openFDA lists it as a Class 2 device under 21 CFR 870.2380. Class II devices are moderate risk and are subject to general and special controls.
Product code QXO covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. Viz.ai, Inc. has 10 AI-enabled devices on the list, and the Cardiovascular panel accounts for 154 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.