INTEGRATED INNOVA - S5I SYSTEM OPTION— 510(k) K111209

Clearance details

Applicant

GE Healthcare

Product code

Code IZI

Device class

Class 2

Regulation

21 CFR 892.1600

Advisory panel

Radiology

Date received

2011-04-29

Decision date

2011-07-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Buc, FR

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Death

9

Malfunction

5,312

Total

5,321

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 →

• Z-1199-2019 — Innova IGS 630, Angiographic X-Ray, s5i system option used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.Class II·Ongoing·GE Healthcare, LLC·20190315
• Z-2387-2018 — Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray SystemsClass II·Terminated·GE Medical Systems, SCS·20180329

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111209.