System, Imaging, Pulsed Doppler, Ultrasonic

How Is IYN Classified?

System, Imaging, Pulsed Doppler, Ultrasonic is FDA product code IYN, Class 2, 21 CFR 892.1550.

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 201 clearances under this code; the FDA took a median of 106 days from receipt to decision on them.

17 went the Special 510(k) route, the one for a change to the applicant’s own cleared device. 29 were reviewed by an accredited third party.

What Has Gone Wrong With It?

The FDA has recorded 298 recalls under this product code since 2003. 2 were by a company in China. The root causes the FDA records most often are Device Design (112), Software design (94) and Component design/selection (11).

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