Product code EAM— Radiology

CRONEX QUANTA III INTENSIFYING SCREENS

Classification name
Screen, Intensifying, Radiographic
Device class
Class 1
Regulation
21 CFR 892.1960
Advisory panel
Radiology
Total cleared
35
First cleared
Most recent

Market context for product code EAM

FDA has cleared 35 devices under product code EAM between 1977 and 1997, filed by 12 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 EAM

Recent clearances under product code EAM

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