Hitachi Medical Systems America, Inc. - FDA 510(k) Cleared Devices
100
Total
100
Cleared
0
Denied
100 devices
Cleared
Mar 07, 2000
AIRIS II
Radiology
71d
Cleared
Oct 08, 1999
AIRIS, AIRIS II
Radiology
63d
Cleared
May 24, 1999
HITACHI VERSIFLEX
Radiology
42d
Cleared
Feb 08, 1999
AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE
Radiology
70d
Cleared
Jan 25, 1999
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE
Radiology
56d
Cleared
Dec 11, 1998
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000
Radiology
11d
Cleared
Dec 11, 1998
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II
Radiology
11d
Cleared
May 11, 1998
AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE
Radiology
77d
Cleared
Feb 26, 1998
STRATIS II
Radiology
90d
Cleared
Feb 09, 1998
AIRIS II
Radiology
91d
Cleared
Jul 03, 1997
VERSION 4 OPERATING SYSTEM SOFTWARE
Radiology
87d
Cleared
Jun 06, 1997
MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)
Radiology
78d
Cleared
Feb 26, 1997
HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)
Radiology
72d
Cleared
Sep 05, 1996
HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6...
Radiology
108d
Cleared
Aug 14, 1996
1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE)
Radiology
78d
Cleared
Jul 25, 1996
AIRIS
Radiology
71d
Cleared
Jun 21, 1996
ECG MONITOR MODEL DS-3130/3140
Radiology
88d
Cleared
Mar 05, 1996
VERSION 3.7 OPERATING SYSTEM SOFTWARE
Radiology
49d
Cleared
Oct 23, 1995
IRIS BILATERAL TMJ
Radiology
104d
Cleared
Oct 17, 1995
QD BILATERAL BREAST COIL
Radiology
96d
Cleared
Sep 12, 1995
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
Radiology
25d
Cleared
May 24, 1995
AIRIS
Radiology
215d
Cleared
May 12, 1995
MRH-1500
Radiology
282d
Cleared
Mar 21, 1995
STRATIS
Radiology
138d
Cleared
Dec 30, 1994
2D,3D, TOF MR ANGIOGRAPHY
Radiology
149d
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