Isoray Medical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles, GammaTile
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Isoray Medical, Inc. Radiology ✕
5 devices
Cleared
Dec 31, 2020
Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18...
Radiology
142d
Cleared
Jul 06, 2018
GammaTile
Radiology
129d
Cleared
Aug 05, 2011
GLIASITE RTS
Radiology
28d
Cleared
Aug 28, 2009
PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED...
Radiology
17d
Cleared
Aug 07, 2009
PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5
Radiology
23d