DeviceClearance

Product code JWM— Radiology

STAR

Classification name
System, Tomographic, Nuclear
Device class
Class 2
Regulation
21 CFR 892.1310
Advisory panel
Radiology
Total cleared
17
First cleared
Most recent

Market context for product code JWM

FDA has cleared 17 devices under product code JWM between 1978 and 1991, filed by 8 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

Top applicants under product code JWM

Recent clearances under product code JWM

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