Interventional Fluoroscopic X-Ray System

What Is This Device?

Interventional fluoroscopy

How Is OWB Classified?

Interventional Fluoroscopic X-Ray System is FDA product code OWB, Class 2, 21 CFR 892.1650.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 6 clearances under this code; the FDA took a median of 229 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 624 recalls under this product code since 2008. None was by a company in China. 20 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (238), Software design (104) and Component design/selection (47). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.