FDA 510(k) Applications for Medical Device Product Code: MOT (Irradiator, Blood To Prevent Graft Versus Host Disease)

FDA 510(k) Applications for Medical Device Product Code "MOT"
(Irradiator, Blood To Prevent Graft Versus Host Disease)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K181737	Best Theratronics Limited	Raycell MK1	01/02/2019
K161324	Best Theratronics Limited	Raycell Mk2	08/12/2016
K172087	Hitachi Ltd.	SANGRAY	10/27/2017
K050963	MDS NORDION	GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN	05/20/2005
K032684	MDS NORDION	RAYCELL	09/26/2003
K051065	MDS NORDION	RAYCELL X-RAY BLOOD IRRADIATOR	05/26/2005
K963497	NORDION INTERNATIONAL, INC.	GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0	11/08/1996
K201177	R3 X-Ray L.L.C	RadGil2	08/17/2020
K082921	RAD SOURCE TECHNOLOGIES, INC.	RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400	02/17/2009
K974210	RAD-SOURCE, INC.	SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000	03/30/1998