FDA Product Code
FDA Product Code SHE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.8200
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN250007 | Delivery Date AI | Ultrasound AI | 2026-02-11 | Direct | — |
Product code SHE · Class II · Radiology. Data: openFDA.