QXRClass II
Vaginal Hydrogel Packing System
21 CFR 892.5735 / Radiology
QXR is the FDA product code for Vaginal Hydrogel Packing System, a class II device type, regulated under 21 CFR 892.5735. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QXR
- Device name
- Vaginal Hydrogel Packing System
- 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.
- Regulation
- 21 CFR 892.5735
- Device class
- Class II
- Review panel
- Radiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QXR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2023 | 1 |
Applicants with the most clearances
Product code QXR| Applicant | Clearances |
|---|---|
| Brachyfoam, Inc. D/B/A Advaray | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.