Hitachi Medical Systems America, Inc.

FDA 510(k) & PMA Approved Devices — 95 products

Total Devices95

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K163528	HITACHI Supria Whole-body X-ray CT System Phase 3	JAK	2017-03-03	View
510(k)	K162079	TRILLIUM Oval Head Coil 32	MOS	2016-09-16	View
510(k)	K161748	SUPRIA w/guideShot Option	JAK	2016-08-17	View
510(k)	K160152	Trillium Oval V 5.1 MRI System	LNH	2016-05-20	View
510(k)	K153547	ECHELON Oval V 5.1 MRI System	LNH	2016-03-31	View
510(k)	K123509	SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM	JAK	2013-03-29	View
510(k)	K113341	GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM	JAK	2012-05-03	View
510(k)	K113145	ECHELON OVAL MRI SYSTEM	LNH	2012-05-01	View
510(k)	K110673	HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER	IYN	2011-09-27	View
510(k)	K101888	SCENARIA WHOLE-BODY X-RAY CT SYSTEM	JAK	2011-04-08	View
510(k)	K110120	ECHELON RAPID CARDIAC COIL	MOS	2011-02-25	View
510(k)	K102889	HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON	MOS	2010-12-20	View
510(k)	K102901	HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER	IYN	2010-10-27	View
510(k)	K093466	HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS	IYO	2010-06-17	View
510(k)	K093044	OASIS MRI SYSTEM	LNI	2010-03-16	View
510(k)	K091103	GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS	JAK	2009-06-15	View
510(k)	K083533	ECHELON C MRI SYSTEM	LNH	2009-02-17	View
510(k)	K083086	ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)	MOS	2008-12-05	View
510(k)	K081745	ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL	MOS	2008-08-12	View
510(k)	K081198	ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N	MOS	2008-06-18	View