SHE — Radiological Software System For Delivery Date Prediction Class II
FDA product code SHE covers "Radiological Software System For Delivery Date Prediction", a Class II medical device regulated under 21 CFR 892.8200. Submissions are reviewed by the Radiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SHE
- Device Class
- Class II
- Regulation Number
- 892.8200
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Definition
A radiological software system for delivery date prediction is a software-only device that analyzes obstetric radiological images to predict the delivery date of a pregnancy. The device output does not replace a clinician's review or judgment on the progression of a pregnancy and should be used in conjunction with other clinical and diagnostic findings. The device does not identify at-risk pregnancies or identify specific complications.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250007 | Ultrasound Ai | Delivery Date AI | Feb 11, 2026 |