Radiological Image Processing Software For Radiation Therapy
QKB · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.2050
Classification
FDA Product Code
QKB
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 semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code.