Device type

Automated Radiological Image Processing Software

Product code QIH · Class II · 21 CFR 892.2050 · Radiology

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.

FDA classification database