QXR
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Vaginal Hydrogel Packing System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.5735
- Medical specialty
- Radiology
- FDA definition
- A vaginal hydrogel packing system is a non-powered positioning device composed of a flexible container filled with a hydrogel. The device is intended to reduce the radiation dose delivered to adjacent pelvic organs by temporarily displacing the vaginal wall and adjacent pelvic tissues during radiation therapy treatment planning and delivery.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BrachyGel Vaginal Hydrogel Packing System (DEN220052) | Brachyfoam, Inc. D/B/A Advaray | 2023-08-22 |
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