Image-Intensified Fluoroscopic X-Ray System, Mobile

What Is It?

Fluoroscopy of the human body.

How Is OXO Classified?

Image-Intensified Fluoroscopic X-Ray System, Mobile is FDA product code OXO, Class 2, 21 CFR 892.1650.

How Does It Reach the US Market?

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 11 clearances under this code; the FDA took a median of 104 days from receipt to decision on them.

3 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Has Gone Wrong With It?

The FDA has recorded 49 recalls under this product code since 2006. 1 was by a company in China. 2 are Class I, the most serious grade.

The root causes the FDA records most often are Software design (15), Process control (10) and Radiation Control for Health and Safety Act (9). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.