SAX
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1600
- Medical specialty
- Ophthalmic
- FDA definition
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Notal Vision Home Optical Coherence Tomography (OCT) System (DEN230043) | Notal Vision, Inc. | 2024-05-15 |
Track SAX automatically
Every clearance here is in the API, with alerts when new ones post.