SAX — Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device Class II
FDA product code SAX covers "Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device", a Class II medical device regulated under 21 CFR 886.1600. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SAX
- Device Class
- Class II
- Regulation Number
- 886.1600
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230043 | notal vision | Notal Vision Home Optical Coherence Tomography (OCT) System | May 15, 2024 |