Medical Device Manufacturer · US , Richland , WA

Isoray, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2003

Recent clearances: CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS, CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE, LAWRENCE CSERION, MODEL CS-1

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

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

3 devices

1-3 of 3

Cleared Dec 17, 2013

CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTS

Radiology · 84d

Cleared Nov 09, 2006

CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE

Radiology · 86d

Cleared Mar 28, 2003

LAWRENCE CSERION, MODEL CS-1

Radiology · 71d