QIH

Automated Radiological Image Processing Software

Product code

QIH

Device name

Automated Radiological Image Processing Software

Device class

Class 2

21 CFR

21 CFR 892.2050

Medical specialty

Radiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

244

Summaries archived here

219 (direct download)

510(k) clearances (all years, FDA)

325 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (244)

Last three years. Most recent: 2026-08-26.

219 summaries are archived here for direct download.

124 more not listed.