DeviceClearance

Product code IYE— Radiology

AlignRT Plus

Classification name
Accelerator, Linear, Medical
Device class
Class 2
Regulation
21 CFR 892.5050
Advisory panel
Radiology
Total cleared
736
First cleared
Most recent

Market context for product code IYE

FDA has cleared 736 devices under product code IYE between 1977 and 2026, filed by 244 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 IYE

Adverse events under product code IYE

product code IYE
Malfunction
455
Other
3
Total
458

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 IYE

1–100 of 736

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