510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203594Substantially Equivalent

EyeCTester

Neuro-Eye Diagnostic Systems, LLC, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203594 is the FDA 510(k) clearance record for EyeCTester, a class I device, cleared for Neuro-Eye Diagnostic Systems, LLC on under FDA product code QTW (Digital Amsler Grid). FDA's definition for product code QTW 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". FDA records list one 510(k) clearance for Neuro-Eye Diagnostic Systems, LLC. As of , FDA records show no recalls naming K203594.

Clearance record

Decision date
Received
(637 days to decision)
Product code
QTW Digital Amsler Grid
Regulation
21 CFR 886.1330
Device class
Class I
Review panel
Ophthalmic
Applicant
Neuro-Eye Diagnostic Systems, LLC 2020 Quenby St., Houston TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QTW

Trailing 12 months

FDA records hold no clearances under product code QTW in the trailing twelve months.

FDA records show no clearances under product code QTW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QTW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260