510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QTOClass I

Digital Visual Acuity Test

21 CFR 886.1150 / Ophthalmic
FDA source (opens on fda.gov)

QTO is the FDA product code for Digital Visual Acuity Test, a class I device type, regulated under 21 CFR 886.1150. FDA's definition for this code reads: "A Digital visual acuity testing system is intended as an aid in the assessment of visual acuity in patients". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QTO
Device name
Digital Visual Acuity Test
FDA definition
A Digital visual acuity testing system is intended as an aid in the assessment of visual acuity in patients.
Regulation
21 CFR 886.1150
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QTO

By decision year
1 clearance under product code QTO with a decision year between 2022 and 2022, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QTO by decision year
YearClearances
20221

Applicants with the most clearances

Product code QTO
Applicants holding the most 510(k) clearances under product code QTO
ApplicantClearances
Visibly1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 32 companies shown, in name order