Eye Prime— 510(k) K190786

Substantially Equivalent

Ellex Medical Pty, Ltd.

FDA 510(k) clearance K190786 for Eye Prime, Substantially Equivalent on 2019-04-11. Applicant: Ellex Medical Pty, Ltd..

Clearance details

Applicant: Ellex Medical Pty, Ltd.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2019-03-27
Decision date: 2019-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mawson Lakes, AU

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.