De Novo Classifications
FDA submissions for De Novo Classifications in the Radiology (RA) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 892.8200–892.8500
CFR Part: 892
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| SHE | Radiological Software System For Delivery Date Prediction | 892.8200 | 2 | 1 |
| SEZ | Radiological Software Device To Predict Future Breast Cancer Risk | 892.8500 | 2 | 1 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| DEN250007 | Delivery Date AI | Ultrasound AI | Feb 11, 2026 |
| DEN240047 | Allix5 | Clairity, Inc. | May 30, 2025 |
