QXR — Vaginal Hydrogel Packing System Class II
Classification Details
- Product Code
- QXR
- Device Class
- Class II
- Regulation Number
- 892.5735
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN220052 | brachyfoam, inc. d/b/a advaray | BrachyGel Vaginal Hydrogel Packing System | August 22, 2023 |