# Automated Radiological Image Processing Software
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 287
- **Registered establishments:** 213
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QIH)
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