QXR · Class II · 21 CFR 892.5735

FDA Product Code QXR: Vaginal Hydrogel Packing System

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.

Leading manufacturers include Brachyfoam, Inc. D/B/A Advaray.

1
Total
0
Cleared
362d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Vaginal Hydrogel Packing System Devices (Product Code QXR)

1 devices
1–1 of 1
Not Cleared Aug 22, 2023
BrachyGel Vaginal Hydrogel Packing System
DEN220052
Brachyfoam, Inc. D/B/A Advaray
Radiology · 362d

About Product Code QXR - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QXR since 2023, with 0 receiving FDA clearance (average review time: 362 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QXR devices are reviewed by the Radiology panel. Browse all Radiology devices →