Medical Device Manufacturer · US , Denton , TX

International Isotopes, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1998

Recent clearances: I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401, IMAGYN 125 I SEED, MODEL IS 125

View 2 510(k) Devices ↓ Official Website

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - International Isotopes, Inc. Radiology ✕

2 devices

1-2 of 2

Cleared Sep 21, 1999

I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401

Radiology · 19d

Cleared Jul 31, 1998

IMAGYN 125 I SEED, MODEL IS 125

Radiology · 18d