System, Planning, Radiation Therapy Treatment

What Is FDA Product Code MUJ?

System, Planning, Radiation Therapy Treatment is FDA product code MUJ, Class 2, 21 CFR 892.5050.

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. Chinese applicants hold 1 clearance under this code; the FDA took 209 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 267 recalls under this product code since 0010. None was by a company in China. The root causes the FDA records most often are Software design (143), Device Design (19) and Software Design Change (7).

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