Product code ITY— Radiology

CRISA

Classification name
Assembly, Tube Housing, X-Ray, Diagnostic
Device class
Class 1
Regulation
21 CFR 892.1760
Advisory panel
Radiology
Total cleared
40
First cleared
Most recent

Market context for product code ITY

FDA has cleared 40 devices under product code ITY between 1976 and 2000, filed by 27 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code ITY

Adverse events under product code ITY

product code ITY
Other
1
Total
1

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 ITY

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