Medical Device Manufacturer · US , Twinsburg , OH

Hitachi Medical Systems America, Inc. - FDA 510(k) Cleared Devices

100 submissions · 100 cleared · Since 1991
100
Total
100
Cleared
0
Denied
99 devices
26-50 of 99
Cleared Feb 11, 2008
OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL...
K080062 · MOS
Radiology · 33d
Cleared Sep 21, 2007
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K072279 · LNH
Radiology · 36d
Cleared Aug 28, 2007
ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM
K071806 · JAK
Radiology · 57d
Cleared Jun 28, 2007
ECHELON SPECTROSCOPY PACKAGE
K071506 · LNI
Radiology · 27d
Cleared Dec 21, 2006
HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER
K063518 · IYN
Radiology · 30d
Cleared Dec 12, 2006
ECHELON MR-RCC-150 CARDIAC COIL
K063513 · MOS
Radiology · 21d
Cleared Oct 05, 2006
ECHELON SHOULDER COIL
K062556 · MOS
Radiology · 36d
Cleared Aug 18, 2006
HHF1 ECHELON MULTI-PURPOSE COIL
K061950 · MOS
Radiology · 39d
Cleared Feb 17, 2006
CXR16
K053148 · JAK
Radiology · 99d
Cleared Jan 24, 2006
ALTAIRE INTERVENTIONAL MR PACKAGE
K053309 · LNH
Radiology · 57d
Cleared Sep 27, 2005
HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
K052172 · LNH
Radiology · 49d
Cleared Apr 07, 2005
ALTAIRE
K050602 · LNH
Radiology · 29d
Cleared Feb 28, 2005
AIRIS ELITE RAPID BODY COIL
K050307 · MOS
Radiology · 20d
Cleared Sep 17, 2004
SCEPTREP3 PET/CT
K042428 · KPS
Radiology · 9d
Cleared Apr 21, 2004
HITACHI PRESTO
K040902 · JAK
Radiology · 14d
Cleared Oct 20, 2003
HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM
K033248 · MUH
Radiology · 13d
Cleared Sep 29, 2003
AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE
K032232 · LNH
Radiology · 70d
Cleared Aug 22, 2003
EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
K032503 · IYN
Radiology · 9d
Cleared Oct 11, 2002
HITACHI ALTAIRE
K022390 · LNH
Radiology · 80d
Cleared Aug 15, 2002
ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM
K021751 · MOS
Radiology · 79d
Cleared Jul 02, 2002
SCEPTRE-VS
K021314 · LLZ
Radiology · 68d
Cleared Mar 22, 2002
PRONTO
K014240 · JAK
Radiology · 86d
Cleared Oct 17, 2000
HITACHI ALTAIRE
K002420 · LNH
Radiology · 70d
Cleared Jul 06, 2000
HITACHI AIRIS II
K001334 · LNH
Radiology · 70d
Cleared Mar 07, 2000
AIRIS II
K994378 · MOS
Radiology · 71d

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