System, Nuclear Magnetic Resonance Imaging

How Is LNH Classified?

System, Nuclear Magnetic Resonance Imaging is FDA product code LNH, Class 2, 21 CFR 892.1000.

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 66 clearances under this code; the FDA took a median of 90 days from receipt to decision on them.

12 went the Special 510(k) route, the one for a change to the applicant’s own cleared device. 14 were reviewed by an accredited third party.

What Has Gone Wrong With It?

The FDA has recorded 699 recalls under this product code since 2002. 5 were by a company in China. 22 are Class I, the most serious grade.

The root causes the FDA records most often are Device Design (122), Software design (97) and Nonconforming Material/Component (58). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.