Automated Radiological Image Processing Software

What Is This Device?

To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance.

Adaptive AI algorithms are not within scope of this product code.

What Is FDA Product Code QIH?

Automated Radiological Image Processing Software is FDA product code QIH, Class 2, 21 CFR 892.2050.

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. Chinese applicants hold 12 clearances under this code; the FDA took a median of 221 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 2 recalls under this product code since 2021. None was by a company in China. The root causes the FDA records most often are Software change control (1) and Software design (1).

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