Coil, Magnetic Resonance, Specialty

How Is MOS Classified?

Coil, Magnetic Resonance, Specialty is FDA product code MOS, 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 23 clearances under this code; the FDA took a median of 84 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. 5 were reviewed by an accredited third party.

What Do the Recalls Say?

The FDA has recorded 38 recalls under this product code since 2006. None was by a company in China. 3 are Class I, the most serious grade.

The root causes the FDA records most often are Use error (13), Nonconforming Material/Component (11) and Device Design (5). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.