1 device · 1 company · 2024
Product code SAX: Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
1 device under product code SAX, 2024, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device. 21 CFR 886.1600, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Notal Vision Home Optical Coherence TomographyDEN230043 · De Novo | Notal Vision Inc | Ophthalmic | database entry |
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