SAX

Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

Product code

SAX

Device name

Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

Device class

Class 2

21 CFR

21 CFR 886.1600

Medical specialty

Ophthalmic

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-05-15.