Product code IWT— Radiology

C.B. RADIOLOGY DESIGN GONADSHIELD

Classification name
Shield, Gonadal
Device class
Class 1
Regulation
21 CFR 892.6500
Advisory panel
Radiology
Total cleared
2
First cleared
Most recent

Market context for product code IWT

FDA has cleared 2 devices under product code IWT between 1983 and 1993, filed by 2 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

Top applicants under product code IWT

Recent clearances under product code IWT

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