# Vaginal Hydrogel Packing System
> **Product code: QXR** · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.5735
## Classification
- **FDA Product Code:** QXR
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 892.5735
- **Review panel:** RA
- **Medical specialty:** Radiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QXR)
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