QXR

Vaginal Hydrogel Packing System

Product code

QXR

Device name

Vaginal Hydrogel Packing System

Device class

Class 2

21 CFR

21 CFR 892.5735

Medical specialty

Radiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).