System, X-Ray, Tomography, Computed

How Is JAK Classified?

System, X-Ray, Tomography, Computed is FDA product code JAK, Class 2, 21 CFR 892.1750.

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 41 clearances under this code; the FDA took a median of 116 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. 7 were reviewed by an accredited third party.

What Do the Recalls Say?

The FDA has recorded 865 recalls under this product code since 2002. 48 were by a company in China. The root causes the FDA records most often are Software design (292), Radiation Control for Health and Safety Act (90) and Device Design (71).

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