DeviceClearance

Product code IZI— Radiology

SPY FLUORESCENT IMAGING SYSTEM

Classification name
System, X-Ray, Angiographic
Device class
Class 2
Regulation
21 CFR 892.1600
Advisory panel
Radiology
Total cleared
199
First cleared
Most recent

Market context for product code IZI

FDA has cleared 199 devices under product code IZI between 1978 and 2026, filed by 90 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code IZI

Adverse events under product code IZI

product code IZI
Death
9
Malfunction
5,312
Total
5,321

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

Recent clearances under product code IZI

1–100 of 199

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