QIH · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2050
Classification
FDA Product Code
QIH
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 892.2050
Review panel
RA
Medical specialty
Radiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.