ELLEX INNOVATIVE IMAGING EYE CUBED V4— 510(k) K083061

Name: FDA 510(k) clearance K083061
Creator: U.S. Food and Drug Administration
Published: 2009-01-09

Substantially Equivalent

Ellex, Inc.

FDA 510(k) clearance K083061 for ELLEX INNOVATIVE IMAGING EYE CUBED V4, Substantially Equivalent on 2009-01-09. Applicant: Ellex, Inc.. Device class: 2.

Clearance details

Applicant: Ellex, Inc.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2008-10-14
Decision date: 2009-01-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYO

view all

K253452 — Accuro 3S2026-07-24
K260190 — ARTHUR2026-06-18
K252237 — EdgeFlow UW202026-04-17
K254021 — Accuro XV2026-04-09
K253898 — QT Scanner 2000 Model A2026-03-04

More clearances from Ellex, Inc.

view all

K103608 — I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND2010-12-27

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.