# Radiological Image Processing Software For Radiation Therapy
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 46
- **Registered establishments:** 21
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QKB)
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