Notal Vision Home Optical Coherence Tomography (OCT) System is an AI-enabled medical device from Notal Vision Inc that the U.S. FDA granted through De Novo DEN230043 on May 15, 2024. Its lead review panel is Ophthalmic and its primary product code is SAX (Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device).
See also all FDA AI clearances in 2024.
Key facts
| Submission number | DEN230043 |
|---|---|
| Pathway | De Novo |
| Date of final decision | |
| Company (FDA list) | Notal Vision Inc |
| Lead review panel | Ophthalmic |
| Primary product code | SAX — Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device |
| Applicant (openFDA) | Notal Vision, Inc. |
| Applicant location | Manassas, VA, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 886.1600 |
| 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. Notal Vision Home Optical Coherence Tomography (OCT) System went through this pathway (DEN230043).
openFDA lists it as a Class 2 device under 21 CFR 886.1600. Class II devices are moderate risk and are subject to general and special controls.
Product code SAX covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Notal Vision Inc has 1 AI-enabled device on the list, and the Ophthalmic panel accounts for 10 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.