Display, Cathode-Ray Tube, Medical

What Is FDA Product Code DXJ?

Display, Cathode-Ray Tube, Medical is FDA product code DXJ, Class 2, 21 CFR 870.2450.

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 2 clearances under this code; the FDA took a median of 120 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 21 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Software design (10), Component design/selection (3) and Labeling design (1).

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