Solid State X-Ray Imager (Flat Panel/Digital Imager)

What Is FDA Product Code MQB?

Solid State X-Ray Imager (Flat Panel/Digital Imager) is FDA product code MQB, Class 2, 21 CFR 892.1680.

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 37 clearances under this code; the FDA took a median of 30 days from receipt to decision on them.

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

What Do the Recalls Say?

The FDA has recorded 195 recalls under this product code since 2004. None was by a company in China. The root causes the FDA records most often are Device Design (63), Software design (27) and Nonconforming Material/Component (20).

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