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

Digital Amsler Grid

21 CFR 886.1330 / Ophthalmic
FDA source (opens on fda.gov)

QTW is the FDA product code for Digital Amsler Grid, a class I device type, regulated under 21 CFR 886.1330. FDA's definition for this code reads: "A Digital Amsler grid is intended as an aid in detection of central visual irregularities caused by changes in the visual pathway 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
QTW
Device name
Digital Amsler Grid
FDA definition
A Digital Amsler grid is intended as an aid in detection of central visual irregularities caused by changes in the visual pathway in patients.
Regulation
21 CFR 886.1330
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 QTW

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

Applicants with the most clearances

Product code QTW
Applicants holding the most 510(k) clearances under product code QTW
ApplicantClearances
Neuro-Eye Diagnostic Systems, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code