QIH — Automated Radiological Image Processing Software Class II

FDA Device Classification

Classification Details

Product Code
QIH
Device Class
Class II
Regulation Number
892.2050
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

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.

Recent 510(k) Clearances

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