QIH

319 FDA 510(k) clearances · Product code

FDA profile

Official device name

Automated Radiological Image Processing Software

Device class

Class II (moderate risk)

Regulation

21 CFR 892.2050

Medical specialty

Radiology

FDA definition

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.

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