System, X-Ray, Extraoral Source, Digital

How Is MUH Classified?

System, X-Ray, Extraoral Source, Digital is FDA product code MUH, Class 2, 21 CFR 872.1800.

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 78 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 Do the Recalls Say?

The FDA has recorded 9 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Device Design (2), Software design (2) and Component design/selection (2).

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