System, Imaging, Pulsed Echo, Ultrasonic

How Is IYO Classified?

System, Imaging, Pulsed Echo, Ultrasonic is FDA product code IYO, Class 2, 21 CFR 892.1560.

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 45 clearances under this code; the FDA took a median of 73 days from receipt to decision on them.

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

What Do the Recalls Say?

The FDA has recorded 82 recalls under this product code since 2000. None was by a company in China. The root causes the FDA records most often are Software design (25), Device Design (15) and Software change control (11).

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