Hitachi Medical Systems America, Inc.
100 FDA 510(k) clearances · Manufacturer
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| Record | Firm | Date |
|---|---|---|
| HITACHI Supria Whole-body X-ray CT System Phase 3 (K163528) | Hitachi Medical Systems America, Inc. | 2017-03-03 |
| TRILLIUM Oval Head Coil 32 (K162079) | Hitachi Medical Systems America, Inc. | 2016-09-16 |
| SUPRIA w/guideShot Option (K161748) | Hitachi Medical Systems America, Inc. | 2016-08-17 |
| Trillium Oval V 5.1 MRI System (K160152) | Hitachi Medical Systems America, Inc. | 2016-05-20 |
| ECHELON Oval V 5.1 MRI System (K153547) | Hitachi Medical Systems America, Inc. | 2016-03-31 |
| SCENARIA Phase 3 Whole-body X-ray CT System (K150595) | Hitachi Medical Systems America, Inc. | 2015-10-30 |
| Supria Whole-body X-ray CT System (K150565) | Hitachi Medical Systems America, Inc. | 2015-09-30 |
| ECHELON Oval V 5.0 MRI System (K151015) | Hitachi Medical Systems America, Inc. | 2015-07-29 |
| Sirius Starmobile tiara (K143537) | Hitachi Medical Systems America, Inc. | 2015-03-06 |
| TRILLIUM Oval MR System (K142734) | Hitachi Medical Systems America, Inc. | 2015-03-02 |
| SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM (K123509) | Hitachi Medical Systems America, Inc. | 2013-03-29 |
| GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM (K113341) | Hitachi Medical Systems America, Inc. | 2012-05-03 |
| ECHELON OVAL MRI SYSTEM (K113145) | Hitachi Medical Systems America, Inc. | 2012-05-01 |
| HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER (K110673) | Hitachi Medical Systems America, Inc. | 2011-09-27 |
| SCENARIA WHOLE-BODY X-RAY CT SYSTEM (K101888) | Hitachi Medical Systems America, Inc. | 2011-04-08 |
| ECHELON RAPID CARDIAC COIL (K110120) | Hitachi Medical Systems America, Inc. | 2011-02-25 |
| HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON (K102889) | Hitachi Medical Systems America, Inc. | 2010-12-20 |
| HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER (K102901) | Hitachi Medical Systems America, Inc. | 2010-10-27 |
| HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS (K093466) | Hitachi Medical Systems America, Inc. | 2010-06-17 |
| OASIS MRI SYSTEM (K093044) | Hitachi Medical Systems America, Inc. | 2010-03-16 |
| GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS (K091103) | Hitachi Medical Systems America, Inc. | 2009-06-15 |
| ECHELON C MRI SYSTEM (K083533) | Hitachi Medical Systems America, Inc. | 2009-02-17 |
| ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) (K083086) | Hitachi Medical Systems America, Inc. | 2008-12-05 |
| ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL (K081745) | Hitachi Medical Systems America, Inc. | 2008-08-12 |
| ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N (K081198) | Hitachi Medical Systems America, Inc. | 2008-06-18 |
| OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 (K080062) | Hitachi Medical Systems America, Inc. | 2008-02-11 |
| MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K072279) | Hitachi Medical Systems America, Inc. | 2007-09-21 |
| ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM (K071806) | Hitachi Medical Systems America, Inc. | 2007-08-28 |
| ECHELON SPECTROSCOPY PACKAGE (K071506) | Hitachi Medical Systems America, Inc. | 2007-06-28 |
| HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER (K063518) | Hitachi Medical Systems America, Inc. | 2006-12-21 |
| ECHELON MR-RCC-150 CARDIAC COIL (K063513) | Hitachi Medical Systems America, Inc. | 2006-12-12 |
| ECHELON SHOULDER COIL (K062556) | Hitachi Medical Systems America, Inc. | 2006-10-05 |
| HHF1 ECHELON MULTI-PURPOSE COIL (K061950) | Hitachi Medical Systems America, Inc. | 2006-08-18 |
| CXR16 (K053148) | Hitachi Medical Systems America, Inc. | 2006-02-17 |
| ALTAIRE INTERVENTIONAL MR PACKAGE (K053309) | Hitachi Medical Systems America, Inc. | 2006-01-24 |
| HHF1 MAGNETIC RESONANCE IMAGING SYSTEM (K052172) | Hitachi Medical Systems America, Inc. | 2005-09-27 |
| ALTAIRE (K050602) | Hitachi Medical Systems America, Inc. | 2005-04-07 |
| AIRIS ELITE RAPID BODY COIL (K050307) | Hitachi Medical Systems America, Inc. | 2005-02-28 |
| SCEPTREP3 PET/CT (K042428) | Hitachi Medical Systems America, Inc. | 2004-09-17 |
| HITACHI PRESTO (K040902) | Hitachi Medical Systems America, Inc. | 2004-04-21 |
| HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM (K033248) | Hitachi Medical Systems America, Inc. | 2003-10-20 |
| AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE (K032232) | Hitachi Medical Systems America, Inc. | 2003-09-29 |
| EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER (K032503) | Hitachi Medical Systems America, Inc. | 2003-08-22 |
| HITACHI ALTAIRE (K022390) | Hitachi Medical Systems America, Inc. | 2002-10-11 |
| ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM (K021751) | Hitachi Medical Systems America, Inc. | 2002-08-15 |
| SCEPTRE-VS (K021314) | Hitachi Medical Systems America, Inc. | 2002-07-02 |
| PRONTO (K014240) | Hitachi Medical Systems America, Inc. | 2002-03-22 |
| ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM (K011320) | Hitachi Medical Systems America, Inc. | 2001-08-09 |
| HITACHI ALTAIRE (K002420) | Hitachi Medical Systems America, Inc. | 2000-10-17 |
| HITACHI AIRIS II (K001334) | Hitachi Medical Systems America, Inc. | 2000-07-06 |
| AIRIS II (K994378) | Hitachi Medical Systems America, Inc. | 2000-03-07 |
| AIRIS, AIRIS II (K992650) | Hitachi Medical Systems America, Inc. | 1999-10-08 |
| HITACHI VERSIFLEX (K991231) | Hitachi Medical Systems America, Inc. | 1999-05-24 |
| AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE (K984280) | Hitachi Medical Systems America, Inc. | 1999-02-08 |
| MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE (K984274) | Hitachi Medical Systems America, Inc. | 1999-01-25 |
| MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II (K984278) | Hitachi Medical Systems America, Inc. | 1998-12-11 |
| MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000 (K984272) | Hitachi Medical Systems America, Inc. | 1998-12-11 |
| AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K980691) | Hitachi Medical Systems America, Inc. | 1998-05-11 |
| STRATIS II (K974498) | Hitachi Medical Systems America, Inc. | 1998-02-26 |
| AIRIS II (K974212) | Hitachi Medical Systems America, Inc. | 1998-02-09 |
| VERSION 4 OPERATING SYSTEM SOFTWARE (K971279) | Hitachi Medical Systems America, Inc. | 1997-07-03 |
| MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52) (K971016) | Hitachi Medical Systems America, Inc. | 1997-06-06 |
| HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30) (K964990) | Hitachi Medical Systems America, Inc. | 1997-02-26 |
| HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE (K961969) | Hitachi Medical Systems America, Inc. | 1996-09-05 |
| 1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE) (K962048) | Hitachi Medical Systems America, Inc. | 1996-08-14 |
| AIRIS (K961876) | Hitachi Medical Systems America, Inc. | 1996-07-25 |
| ECG MONITOR MODEL DS-3130/3140 (K961174) | Hitachi Medical Systems America, Inc. | 1996-06-21 |
| VERSION 3.7 OPERATING SYSTEM SOFTWARE (K960181) | Hitachi Medical Systems America, Inc. | 1996-03-05 |
| IRIS BILATERAL TMJ (K953248) | Hitachi Medical Systems America, Inc. | 1995-10-23 |
| QD BILATERAL BREAST COIL (K953262) | Hitachi Medical Systems America, Inc. | 1995-10-17 |
| MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K953918) | Hitachi Medical Systems America, Inc. | 1995-09-12 |
| AIRIS (K945155) | Hitachi Medical Systems America, Inc. | 1995-05-24 |
| MRH-1500 (K943798) | Hitachi Medical Systems America, Inc. | 1995-05-12 |
| STRATIS (K945386) | Hitachi Medical Systems America, Inc. | 1995-03-21 |
| 2D,3D, TOF MR ANGIOGRAPHY (K943800) | Hitachi Medical Systems America, Inc. | 1994-12-30 |
| VERSION 5 OPERATING SYSTEM SOFTWARE (K943799) | Hitachi Medical Systems America, Inc. | 1994-12-09 |
| QUAD PELVIS COIL (K943321) | Hitachi Medical Systems America, Inc. | 1994-09-23 |
| MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K942560) | Hitachi Medical Systems America, Inc. | 1994-09-09 |
| EXTRA LARGE QUAD FLEX SPINE COIL (K940602) | Hitachi Medical Systems America, Inc. | 1994-05-23 |
| DIAGNOSTIC ULTRASOUND SYSTEM (K915403) | Hitachi Medical Systems America, Inc. | 1994-05-03 |
| 2D, 3D TOF MR ANGIOGRAPHY (K935671) | Hitachi Medical Systems America, Inc. | 1994-03-30 |
| VERSION 3 OPERATING SYSTEM SOFTWARE (K935670) | Hitachi Medical Systems America, Inc. | 1994-03-30 |
| FAST SPIN ECHO (K935664) | Hitachi Medical Systems America, Inc. | 1994-03-16 |
| HITACHI MPR-5000 & MPR-7000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MODIFICATION (K934485) | Hitachi Medical Systems America, Inc. | 1994-01-25 |
| EXTRA LARGE QUAD FLEX SPINE COIL (K934719) | Hitachi Medical Systems America, Inc. | 1994-01-05 |
| FAST SPIN ECHO (K934212) | Hitachi Medical Systems America, Inc. | 1993-12-27 |
| ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000 (K933645) | Hitachi Medical Systems America, Inc. | 1993-11-12 |
| MRH-1500 (K922846) | Hitachi Medical Systems America, Inc. | 1993-06-08 |
| FAST SPIN ECHO MEASURING FUNCTION (K926397) | Hitachi Medical Systems America, Inc. | 1993-03-18 |
| 2D TOF ANGIOGRAHY MEASURING FUNCTION (K925009) | Hitachi Medical Systems America, Inc. | 1993-02-12 |
| MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL (K923140) | Hitachi Medical Systems America, Inc. | 1992-12-24 |
| EUB-405 (K924126) | Hitachi Medical Systems America, Inc. | 1992-12-10 |
| MAGNETIC RESONANCE DIAGNOSTIC DEVICE (K923010) | Hitachi Medical Systems America, Inc. | 1992-08-25 |
| 3D TOF ANGIOGRAPHY MEASURING FUNCTION (K920441) | Hitachi Medical Systems America, Inc. | 1992-07-30 |
| MOBILE MRP-7000 (K920159) | Hitachi Medical Systems America, Inc. | 1992-03-05 |
| MRH-500 (K911993) | Hitachi Medical Systems America, Inc. | 1991-11-22 |
| MRP-5000 & MRP-7000 HS/MR QUADRATURE KNEE COILS (K914263) | Hitachi Medical Systems America, Inc. | 1991-11-22 |
| MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31) (K914019) | Hitachi Medical Systems America, Inc. | 1991-11-01 |
| HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE (K911667) | Hitachi Medical Systems America, Inc. | 1991-05-30 |
| MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION (K911642) | Hitachi Medical Systems America, Inc. | 1991-05-30 |
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