Hitachi Medical Systems America, Inc. - FDA 510(k) Cleared Devices
100
Total
100
Cleared
0
Denied
99 devices
Cleared
Sep 23, 1994
QUAD PELVIS COIL
Radiology
74d
Cleared
Sep 09, 1994
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
Radiology
101d
Cleared
May 23, 1994
EXTRA LARGE QUAD FLEX SPINE COIL
Radiology
102d
Cleared
May 03, 1994
DIAGNOSTIC ULTRASOUND SYSTEM
Radiology
881d
Cleared
Mar 30, 1994
VERSION 3 OPERATING SYSTEM SOFTWARE
Radiology
124d
Cleared
Mar 30, 1994
2D, 3D TOF MR ANGIOGRAPHY
Radiology
124d
Cleared
Mar 16, 1994
FAST SPIN ECHO
Radiology
110d
Cleared
Jan 25, 1994
HITACHI MPR-5000 & MPR-7000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MODIFICATION
Radiology
133d
Cleared
Jan 05, 1994
EXTRA LARGE QUAD FLEX SPINE COIL
Radiology
96d
Cleared
Dec 27, 1993
FAST SPIN ECHO
Radiology
119d
Cleared
Nov 12, 1993
ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000
Radiology
108d
Cleared
Jun 08, 1993
MRH-1500
Radiology
358d
Cleared
Mar 18, 1993
FAST SPIN ECHO MEASURING FUNCTION
Radiology
87d
Cleared
Feb 12, 1993
2D TOF ANGIOGRAHY MEASURING FUNCTION
Radiology
135d
Cleared
Dec 24, 1992
MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL
Radiology
178d
Cleared
Dec 10, 1992
EUB-405
Radiology
115d
Cleared
Aug 25, 1992
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
Radiology
64d
Cleared
Jul 30, 1992
3D TOF ANGIOGRAPHY MEASURING FUNCTION
Radiology
178d
Cleared
Mar 05, 1992
MOBILE MRP-7000
Radiology
51d
Cleared
Nov 22, 1991
MRH-500
Radiology
199d
Cleared
Nov 22, 1991
MRP-5000 & MRP-7000 HS/MR QUADRATURE KNEE COILS
Radiology
60d
Cleared
Nov 01, 1991
MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)
Radiology
53d
Cleared
May 30, 1991
MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION
Radiology
49d
Cleared
May 30, 1991
HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE
Radiology
48d
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