Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
SAX is the FDA product code for Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device, a class II device type, regulated under 21 CFR 886.1600. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SAX
- Device name
- Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
- 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.
- Regulation
- 21 CFR 886.1600
- Device class
- Class II
- Review panel
- Ophthalmic
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SAX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 1 |
Applicants with the most clearances
Product code SAX| Applicant | Clearances |
|---|---|
| Notal Vision Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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