Display, Diagnostic Radiology

What Is It?

The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.

What Is FDA Product Code PGY?

Display, Diagnostic Radiology is FDA product code PGY, Class 2, 21 CFR 892.2050.

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 41 clearances under this code; the FDA took a median of 56 days from receipt to decision on them.

2 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 6 recalls under this product code since 2015. None was by a company in China. The root causes the FDA records most often are Device Design (5) and Process change control (1).

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