System, Radiation Therapy, Radionuclide

How Is IWB Classified?

System, Radiation Therapy, Radionuclide is FDA product code IWB, Class 2, 21 CFR 892.5750.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 2 clearances under this code; the FDA took a median of 192 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 29 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Software design (5), Use error (2) and Labeling False and Misleading (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.