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FDA 510(k) & PMA Approved Devices — 24 products

Total Devices24

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K232185	SM-IV	IZL	2023-08-21	View
510(k)	K222951	SM-V	IZL	2022-11-21	View
510(k)	K221803	PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.	IZL	2022-07-18	View
510(k)	K212291	PHOENIX	IZL	2021-09-14	View
510(k)	K203537	Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems	KPR	2021-02-01	View
510(k)	K202293	Radiographic System Challenge X	KPR	2020-10-07	View
510(k)	K192936	Soltus 500	IZL	2019-11-15	View
510(k)	K192011	PhoeniX	IZL	2019-09-25	View
510(k)	K191813	MobileDiagnost wDR 2.2	IZL	2019-08-02	View
510(k)	K173299	DRAGON X SPSL4HC, DRAGON X SPSL8HC	IZL	2018-01-26	View
510(k)	K161345	RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR	IZL	2016-07-06	View
510(k)	K130883	SEDECAL DIGITAL RADIOGRAPHIC UPGRADE MODEL SDRU-T	MQB	2013-04-18	View
510(k)	K121410	DRAGON LW	IZL	2012-08-02	View
510(k)	K101517	SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY	IZL	2011-08-05	View
510(k)	K111725	MOBILEDIAGNOST WDR	IZL	2011-07-19	View
510(k)	K103522	SEDECAL	IZL	2011-01-26	View
510(k)	K090322	EASY MOVING PLUS, SM-XXHF-YY	IZL	2009-03-17	View
510(k)	K090279	SEDECAL, MILLENNIUM PLUS	KPR	2009-03-11	View
510(k)	K090238	SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS	KPR	2009-02-27	View
510(k)	K063283	DEFINIUM 5000 X-RAY SYSTEM	MQB	2006-11-17	View