QTO

Digital Visual Acuity Test

Product code

QTO

Device name

Digital Visual Acuity Test

Device class

Class 1

21 CFR

21 CFR 886.1150

Medical specialty

Ophthalmic

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

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

FDA classification definition

A Digital visual acuity testing system is intended as an aid in the assessment of visual acuity in patients.

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