FDA product code SAX: 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. It is a Class II device, regulated under 21 CFR 886.1600 and reviewed by the Ophthalmic panel. Devices under SAX reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device |
| Device class | Class II |
| Regulation | 21 CFR 886.1600 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
Recalls for SAX devices
openFDA lists no recalls for product code SAX.
Frequently asked questions
What is FDA product code SAX?
SAX is the FDA product code for home monitoring ophthalmic optical coherence tomography (oct) imaging device. It is a Class II device, regulated under 21 CFR 886.1600 and reviewed by the Ophthalmic panel.
What device class is SAX?
Class II, regulation 21 CFR 886.1600. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SAX
- Run a recall and safety report across every SAX manufacturer
- Watch product code SAX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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