Company ยท US
Hitachi Medical Systems America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2017. Name variants (Inc, Corp, punctuation) are merged.
100510(k) clearances (0 in 12 months)
45recalls (0 in 12 months)
44recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 77 |
| JAK | System, X-Ray, Tomography, Computed | 21 |
| MOS | Coil, Magnetic Resonance, Specialty | 21 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 8 |
| ITX | Transducer, Ultrasonic, Diagnostic | 5 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 |
| LNI | System, Nuclear Magnetic Resonance Spectroscopic | 2 |
| DQA | Oximeter | 1 |
| IWE | Monitor, Patient Position, Light-Beam | 1 |
| IZI | System, X-Ray, Angiographic | 1 |
| IZL | System, X-Ray, Mobile | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 |
| KPS | System, Tomography, Computed, Emission | 1 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 1 |
| LLZ | System, Image Processing, Radiological | 1 |
| MUH | System, X-Ray, Extraoral Source, Digital | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 3, 2017 | K163528 | HITACHI Supria Whole-body X-ray CT System Phase 3 Hitachi Medical Systems America, Inc. | JAK |
| Sep 16, 2016 | K162079 | TRILLIUM Oval Head Coil 32 Hitachi Medical Systems America, Inc. | MOS |
| Aug 17, 2016 | K161748 | SUPRIA w/guideShot Option Hitachi Medical Systems America, Inc. | JAK |
| May 20, 2016 | K160152 | Trillium Oval V 5.1 MRI System Hitachi Medical Systems America, Inc. | LNH |
| Mar 31, 2016 | K153547 | ECHELON Oval V 5.1 MRI System Hitachi Medical Systems America, Inc. | LNH |
| Oct 30, 2015 | K150595 | SCENARIA Phase 3 Whole-body X-ray CT System Hitachi Medical Systems America, Inc. | JAK |
| Sep 30, 2015 | K150565 | Supria Whole-body X-ray CT System Hitachi Medical Systems America, Inc. | JAK |
| Jul 29, 2015 | K151015 | ECHELON Oval V 5.0 MRI System Hitachi Medical Systems America, Inc. | LNH |
| Mar 6, 2015 | K143537 | Sirius Starmobile tiara Hitachi Medical Systems America, Inc. | IZL |
| Mar 2, 2015 | K142734 | TRILLIUM Oval MR System Hitachi Medical Systems America, Inc. | LNH |
| Mar 29, 2013 | K123509 | SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM Hitachi Medical Systems America, Inc. | JAK |
| May 3, 2012 | K113341 | GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM Hitachi Medical Systems America, Inc. | JAK |
| May 1, 2012 | K113145 | ECHELON OVAL MRI SYSTEM Hitachi Medical Systems America, Inc. | LNH |
| Sep 27, 2011 | K110673 | HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER Hitachi Medical Systems America, Inc. | IYN |
| Apr 8, 2011 | K101888 | SCENARIA WHOLE-BODY X-RAY CT SYSTEM Hitachi Medical Systems America, Inc. | JAK |
| Feb 25, 2011 | K110120 | ECHELON RAPID CARDIAC COIL Hitachi Medical Systems America, Inc. | MOS |
| Dec 20, 2010 | K102889 | HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON Hitachi Medical Systems America, Inc. | MOS |
| Oct 27, 2010 | K102901 | HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER Hitachi Medical Systems America, Inc. | IYN |
| Jun 17, 2010 | K093466 | HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS Hitachi Medical Systems America, Inc. | IYO |
| Mar 16, 2010 | K093044 | OASIS MRI SYSTEM Hitachi Medical Systems America, Inc. | LNI |
| Jun 15, 2009 | K091103 | GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS Hitachi Medical Systems America, Inc. | JAK |
| Feb 17, 2009 | K083533 | ECHELON C MRI SYSTEM Hitachi Medical Systems America, Inc. | LNH |
| Dec 5, 2008 | K083086 | ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) Hitachi Medical Systems America, Inc. | MOS |
| Aug 12, 2008 | K081745 | ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL Hitachi Medical Systems America, Inc. | MOS |
| Jun 18, 2008 | K081198 | ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N Hitachi Medical Systems America, Inc. | MOS |
| Feb 11, 2008 | K080062 | OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120 Hitachi Medical Systems America, Inc. | MOS |
| Sep 21, 2007 | K072279 | MAGNETIC RESONANCE DIAGNOSTIC DEVICE Hitachi Medical Systems America, Inc. | LNH |
| Aug 28, 2007 | K071806 | ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM Hitachi Medical Systems America, Inc. | JAK |
| Jun 28, 2007 | K071506 | ECHELON SPECTROSCOPY PACKAGE Hitachi Medical Systems America, Inc. | LNI |
| Dec 21, 2006 | K063518 | HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER Hitachi Medical Systems America, Inc. | IYN |
| Dec 12, 2006 | K063513 | ECHELON MR-RCC-150 CARDIAC COIL Hitachi Medical Systems America, Inc. | MOS |
| Oct 5, 2006 | K062556 | ECHELON SHOULDER COIL Hitachi Medical Systems America, Inc. | MOS |
| Aug 18, 2006 | K061950 | HHF1 ECHELON MULTI-PURPOSE COIL Hitachi Medical Systems America, Inc. | MOS |
| Feb 17, 2006 | K053148 | CXR16 Hitachi Medical Systems America, Inc. | JAK |
| Jan 24, 2006 | K053309 | ALTAIRE INTERVENTIONAL MR PACKAGE Hitachi Medical Systems America, Inc. | LNH |
| Sep 27, 2005 | K052172 | HHF1 MAGNETIC RESONANCE IMAGING SYSTEM Hitachi Medical Systems America, Inc. | LNH |
| Apr 7, 2005 | K050602 | ALTAIRE Hitachi Medical Systems America, Inc. | LNH |
| Feb 28, 2005 | K050307 | AIRIS ELITE RAPID BODY COIL Hitachi Medical Systems America, Inc. | MOS |
| Sep 17, 2004 | K042428 | SCEPTREP3 PET/CT Hitachi Medical Systems America, Inc. | KPS |
| Apr 21, 2004 | K040902 | HITACHI PRESTO Hitachi Medical Systems America, Inc. | JAK |
| Oct 20, 2003 | K033248 | HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM Hitachi Medical Systems America, Inc. | MUH |
| Sep 29, 2003 | K032232 | AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE Hitachi Medical Systems America, Inc. | LNH |
| Aug 22, 2003 | K032503 | EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER Hitachi Medical Systems America, Inc. | IYN |
| Oct 11, 2002 | K022390 | HITACHI ALTAIRE Hitachi Medical Systems America, Inc. | LNH |
| Aug 15, 2002 | K021751 | ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM Hitachi Medical Systems America, Inc. | MOS |
| Jul 2, 2002 | K021314 | SCEPTRE-VS Hitachi Medical Systems America, Inc. | LLZ |
| Mar 22, 2002 | K014240 | PRONTO Hitachi Medical Systems America, Inc. | JAK |
| Aug 9, 2001 | K011320 | ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM Hitachi Medical Systems America, Inc. | DQA |
| Oct 17, 2000 | K002420 | HITACHI ALTAIRE Hitachi Medical Systems America, Inc. | LNH |
| Jul 6, 2000 | K001334 | HITACHI AIRIS II Hitachi Medical Systems America, Inc. | LNH |
Newest 50 of 100.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2021 | Hitachi Medical Systems America Inc Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operativ Terminated |
IYN | K183456 |
| Jan 31, 2020 | Hitachi Medical Systems America Inc UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Dop Terminated |
ITX | K134016 K142368 +1 |
| Oct 16, 2019 | Hitachi Medical Systems America Inc Hitachi Scenaria Whole-body X-ray CT System Terminated |
JAK | K101888 K150595 |
| Jun 29, 2018 | Hitachi Medical Systems America Inc Hitachi Scenaria CT system
Product Usage:
The SCENARIA CT system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The images can Terminated |
JAK | K150595 |
| Jun 18, 2018 | Hitachi Medical Systems America Inc Hitachi Oasis MRI system
Product Usage:
Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and withou Terminated |
LNH | K093044 |
| Oct 20, 2017 | Hitachi Medical Systems America Inc Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures. Terminated |
ITX | K152126 |
| May 2, 2017 | Hitachi Medical Systems America Inc Arietta 70 Ultrasound System
Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation. Terminated |
IYN | K134016 |
| Mar 23, 2017 | Hitachi Medical Systems America Inc Hitachi Echelon MRI System Terminated |
LNH | K083533 |
| Mar 23, 2017 | Hitachi Medical Systems America Inc Hitachi Echelon Oval MRI System Terminated |
LNH | K113145 K151015 +1 |
| Mar 23, 2017 | Hitachi Medical Systems America Inc Hitachi Oasis MRI System Terminated |
LNH | K153547 |
| Jan 6, 2017 | Hitachi Medical Systems America Inc Hitachi Oasis MRI System - C-Spine Coil Terminated |
LNH | K072279 |
| Aug 10, 2015 | Hitachi Medical Systems America Inc Oasis Coil Extension Cable used with Hitachi Oasis MRI System
Product Usage:
The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical informat Terminated |
MOS | K072279 |
| Jun 30, 2015 | Hitachi Medical Systems America Inc Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087 Terminated |
JAK | K101888 |
| Sep 2, 2014 | Hitachi Medical Systems America Inc Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and Terminated |
LNH | K113145 |
| Jun 19, 2013 | Hitachi Medical Systems America Inc Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box.
The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physio Terminated |
LNH | K052172 K072279 +1 |
| Aug 23, 2012 | Hitachi Medical Systems America Inc Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices.
Product Usage:
The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with Terminated |
LNH | K052172 K072279 |
| Jul 19, 2012 | Hitachi Medical Systems America Inc Hitachi Scenaria CT System Software
Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical Terminated |
JAK | K101888 |
| Jun 8, 2011 | Hitachi Medical Systems America Inc Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software - Doppler Trace Measurement program. 510 (k) Numbers: Preirus - K093466 (6/1/10), Avius - K102901 (10/27/10).
The Preirus and Terminated |
IYN | K093466 K102901 |
| May 19, 2010 | Hitachi Medical Systems America Inc Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO Terminated |
MOS | K001334 |
| May 4, 2010 | Hitachi Medical Systems America Inc Hitachi Oasis Magnetic Resonance Scanners Software V1.0C
The intended use: The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal s Terminated |
IWE | K072279 |
| Sep 9, 2009 | Hitachi Medical Systems America Inc EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners,
DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and V12-04A. Terminated |
ITX | K013722 |
| Sep 9, 2009 | Hitachi Medical Systems America Inc EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A. Terminated |
ITX | K013723 |
| Jul 7, 2009 | Hitachi Medical Systems America Inc Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version: 2.11 or less. Terminated |
JAK | K071806 |
| Jul 7, 2009 | Hitachi Medical Systems America Inc Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less. Terminated |
JAK | K040902 |
| Jan 8, 2009 | Hitachi Medical Systems America Inc Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray imaging device that produces cross-sectional images of he body at different angles. The system reconstructs, processes, displays, an Terminated |
JAK | K040902 |
| Aug 23, 2008 | Hitachi Medical Systems America Inc Altaire MRI System Emergency Rundown Switch Unit (ERDU) is intended to provide the physician with physiological and clinical information obtained non-invasive and without the use of ionizing radiation Terminated |
LNH | K002420 |
| Jul 24, 2008 | Hitachi Medical Systems America Inc EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information. Terminated |
LHN | None listed |
| Sep 26, 2007 | Hitachi Medical Systems America Inc Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a two-channel, receive only coil that functions at 29.641 MHz band. It consists of a cable and a coil (imaging) bo Terminated |
LNH | K002420 |
| Nov 4, 2006 | Hitachi Medical Systems America Inc Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150. Terminated |
MOS | K052172 |
| Oct 12, 2006 | Hitachi Medical Systems America Inc MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J. Terminated |
LNH | K911667 K945155 |
| Jun 14, 2006 | Hitachi Medical Systems America Inc Hitachi AIRIS II MRI System Terminated |
LNH | K001334 K974212 |
| Jun 10, 2006 | Hitachi Medical Systems America Inc MRP-7000, AIRIS Magnetic Resonance Imaging Systems Terminated |
LNH | K911667 K945155 |
| Jun 10, 2006 | Hitachi Medical Systems America Inc AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems Terminated |
LNH | K002420 K974212 |
| Jun 10, 2006 | Hitachi Medical Systems America Inc Hitachi Altaire Magnetic Resonance Imaging System Terminated |
LNH | K002420 K022390 |
| Jun 3, 2006 | Hitachi Medical Systems America Inc Hitachi Emission Computed Tomography System
Hitachi CX-4 CT (including SceptreP3 PET-CT) Terminated |
JAK | K040902 K042428 |
| Jun 3, 2006 | Hitachi Medical Systems America Inc Hitachi CXR-4 CT Computed Tomography X-ray System (including SceptreP3 PET/CT) Terminated |
JAK | K040902 K042428 |
| May 31, 2006 | Hitachi Medical Systems America Inc Magnetic Resonance Imaging Device Terminated |
LNH | K002420 K022390 +2 |
| Jan 24, 2006 | Hitachi Medical Systems America Inc The AIRIS II MR System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The Terminated |
LNH | K974212 |
| Jan 24, 2006 | Hitachi Medical Systems America Inc The AIRIS MR System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The MR Terminated |
LNH | K945155 |
| Jun 14, 2005 | Hitachi Medical Systems America Inc Hitachi AIRIS Elite Magnetic Resonance Imaging Device Terminated |
LNH | K032232 |
| Jun 14, 2005 | Hitachi Medical Systems America Inc Hitachi AIRIS II Magnetic Resonance Imaging Device Terminated |
LNH | K001334 K974212 |
| Jun 14, 2005 | Hitachi Medical Systems America Inc Hitachi Altaire Magnetic Resonance Imaging Device. Terminated |
LNH | K002420 K022390 |
| May 17, 2005 | Hitachi Medical Systems America Inc Altaire, Magnetic Resonance Imaging Device. Terminated |
LNH | K002420 K022390 |
| May 3, 2005 | Hitachi Medical Systems America Inc Altaire, Magnetic Resonance Imaging Device. Terminated |
LNH | K002420 K022390 |
| Jul 20, 2004 | Hitachi Medical Systems America Inc Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W. Terminated |
ITX | K013723 |