Medical Device Manufacturer · US , Austin , TX

Radiadyne - FDA 510(k) Cleared Devices

3 submissions · 2 cleared · Since 2009

Recent clearances: OARTRAC SYSTEM, ALATUS VAGINAL BALLOON PACKING SYSTEM

View 3 510(k) Devices ↓

3

Total

2

Cleared

1

Denied

FDA 510(k) Regulatory Record - Radiadyne Radiology ✕

3 devices

1-3 of 3

Cleared Jul 22, 2014

Radiology · 78d

Not Cleared Jan 28, 2014

PROSTATE IMMOBILIZER RECTAL BALLOON

DEN130036 · PCT

Radiology · 197d

Cleared Dec 07, 2009

ALATUS VAGINAL BALLOON PACKING SYSTEM

Radiology · 110d