System, Image Processing, Radiological

What Is FDA Product Code LLZ?

System, Image Processing, Radiological is FDA product code LLZ, 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 168 days from receipt to decision on them.

One went the Special 510(k) route, the one for a change to the applicant’s own cleared device. 6 were reviewed by an accredited third party.

What Do the Recalls Say?

The FDA has recorded 560 recalls under this product code since 2002. None was by a company in China. 3 are Class I, the most serious grade.

The root causes the FDA records most often are Software design (363), Device Design (23) and Software Design Change (15). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.