DeviceClearance

Product code IZL— Radiology

GM85

Classification name
System, X-Ray, Mobile
Device class
Class 2
Regulation
21 CFR 892.1720
Advisory panel
Radiology
Total cleared
237
First cleared
Most recent

Market context for product code IZL

FDA has cleared 237 devices under product code IZL between 1976 and 2026, filed by 123 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 IZL

Adverse events under product code IZL

product code IZL
Other
3
Total
3

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 IZL

1–100 of 237

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