K203594 is an FDA 510(k) clearance for the EyeCTester. This device is classified as a Digital Amsler Grid (Class I - General Controls, product code QTW).
Submitted by Neuro-Eye Diagnostic Systems, LLC (Houston, US). The FDA issued a Cleared decision on September 7, 2022, 637 days after receiving the submission on December 9, 2020.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1330. A Digital Amsler Grid Is Intended As An Aid In Detection Of Central Visual Irregularities Caused By Changes In The Visual Pathway In Patients..
| 510(k) Number | K203594 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2020 |
| Decision Date | September 07, 2022 |
| Days to Decision | 637 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | QTW - Digital Amsler Grid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1330 |
| 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. |