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Automated Radiological Image Processing Software

FDA product code QIH · 334 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.2050
Review panel
RA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-11-13 – 2026-09-25

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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