SAX · Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
Ophthalmic · 21 CFR 886.1600 · Class 2
Overview
| Product Code | SAX |
|---|---|
| Device Name | Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device |
| Regulation | 21 CFR 886.1600 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
A home monitoring ophthalmic imaging device is a prescription self-imaging device that incorporates imaging system hardware and automated image processing and analysis to enable patients at home to provide measurements that are intended for use by a physician for monitoring ophthalmic diseases or conditions in between regularly scheduled assessments. The Notal Vision Home Optical Coherence Tomography (OCT) System is an AI-based home use device indicated for visualization of intraretinal and subretinal hypo-reflective spaces in a 10 by 10-degrees area centered on the point of fixation of eyes diagnosed with neovascular age-related macular degeneration (NV-AMD), providing segmentation and estimation of the volume of these spaces.
Classification Rationale
Class II (special controls). The device is granted under the De Novo process, with risks mitigated by general controls and the identified special controls.
Special Controls
In combination with the general controls of the FD&C Act, the home monitoring ophthalmic imaging device is subject to the following special controls:
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN230043 | Notal Vision Home Optical Coherence Tomography (OCT) System | Notal Vision, Inc. | May 15, 2024 | DENG |
Top Applicants
- Notal Vision, Inc. — 1 clearance
