Eye Prime— 510(k) K190786

Name: FDA 510(k) clearance K190786
Creator: U.S. Food and Drug Administration
Published: 2019-04-11

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.. Device class: 2.

Clearance details

Applicant: Ellex Medical Pty, Ltd.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
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 ↗

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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.