DeviceClearance

Product code IWI— Radiology

CESIUM 137 SOURCE, MODEL CSM-40

Classification name
Source, Isotope, Sealed, Gold, Titanium, Platinum
Device class
Class 2
Regulation
21 CFR 892.5730
Advisory panel
Radiology
Total cleared
6
First cleared
Most recent

Market context for product code IWI

FDA has cleared 6 devices under product code IWI between 1986 and 1998, filed by 6 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 IWI

Recent clearances under product code IWI

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