Hitachi Medical Systems America, Inc.
Hitachi Medical Systems America, Inc. holds FDA 510(k) medical device clearances, first cleared 1991, most recent 2017, with 17 FDA device recalls on record.
Top product codes for Hitachi Medical Systems America, Inc.
FDA recalls by Hitachi Medical Systems America, Inc.
10 most recent of 17- Z-1282-2021 — 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-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, Endoscopy clinical applications.
- Z-1341-2020 — 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 Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel.
- Z-0271-2020 — Hitachi Scenaria Whole-body X-ray CT System
- Z-2839-2018 — 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 be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the SCENARIA can be post processed by the SCENARIA to provide additional information. Post processing capabilities included in the SCENARIA software include CT angiography (CTA), Multiplanar reconstruction (MPR) and volume rendering. Volume datasets acquired by the SCENARIA Phase 3 can be transferred to external devices via a DICOM standard interface. The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.
- Z-2479-2018 — 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 without the use of ionizing radiation. The Oasis system produces transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the head, body, or extremities. The images produced by the MR systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
- Z-0816-2018 — 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.
- Z-2090-2017 — Arietta 70 Ultrasound System Intended for use by trained personnel (doctor, sonographer. etc.) for the diagnostic Ultrasound evaluation.
- Z-1096-2017 — Hitachi Oasis MRI System - C-Spine Coil
- Z-2392-2016 — Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
- Z-1542-2017 — Hitachi Echelon MRI System
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Hitachi Medical Systems America, Inc.
- K163528 — HITACHI Supria Whole-body X-ray CT System Phase 3
- K162079 — TRILLIUM Oval Head Coil 32
- K161748 — SUPRIA w/guideShot Option
- K160152 — Trillium Oval V 5.1 MRI System
- K153547 — ECHELON Oval V 5.1 MRI System
- K150595 — SCENARIA Phase 3 Whole-body X-ray CT System
- K150565 — Supria Whole-body X-ray CT System
- K151015 — ECHELON Oval V 5.0 MRI System
- K143537 — Sirius Starmobile tiara
- K142734 — TRILLIUM Oval MR System
- K123509 — SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM
- K113341 — GUIDESHOT OPTION, SCENARIA WHOLE-BODY X-RAY CT SYSTEM
- K113145 — ECHELON OVAL MRI SYSTEM
- K110673 — HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER
- K101888 — SCENARIA WHOLE-BODY X-RAY CT SYSTEM
- K110120 — ECHELON RAPID CARDIAC COIL
- K102889 — HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON
- K102901 — HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER
- K093466 — HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS
- K093044 — OASIS MRI SYSTEM
- K091103 — GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS
- K083533 — ECHELON C MRI SYSTEM
- K083086 — ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)
- K081745 — ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL
- K081198 — ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N
- K080062 — OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120
- K072279 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- K071806 — ECLOS COMPUTED TOMOGRAPHY X-RAY SYSTEM
- K071506 — ECHELON SPECTROSCOPY PACKAGE
- K063518 — HI VISION 900 DIAGNOSTIC ULTRASOUND SCANNER
- K063513 — ECHELON MR-RCC-150 CARDIAC COIL
- K062556 — ECHELON SHOULDER COIL
- K061950 — HHF1 ECHELON MULTI-PURPOSE COIL
- K053148 — CXR16
- K053309 — ALTAIRE INTERVENTIONAL MR PACKAGE
- K052172 — HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
- K050602 — ALTAIRE
- K050307 — AIRIS ELITE RAPID BODY COIL
- K042428 — SCEPTREP3 PET/CT
- K040902 — HITACHI PRESTO
- K033248 — HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM
- K032232 — AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE
- K032503 — EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
- K022390 — HITACHI ALTAIRE
- K021751 — ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM
- K021314 — SCEPTRE-VS
- K014240 — PRONTO
- K011320 — ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM
- K002420 — HITACHI ALTAIRE
- K001334 — HITACHI AIRIS II
- K994378 — AIRIS II
- K992650 — AIRIS, AIRIS II
- K991231 — HITACHI VERSIFLEX
- K984280 — AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE
- K984274 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE
- K984272 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000
- K984278 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II
- K980691 — AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- K974498 — STRATIS II
- K974212 — AIRIS II
- K971279 — VERSION 4 OPERATING SYSTEM SOFTWARE
- K971016 — MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)
- K964990 — HITACHI SX-VA30 C-ARM FLUOROSCOPIC/ANGIOGRAPHIC SYSTEM (SX-VA30)
- K961969 — HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE
- K962048 — 1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE)
- K961876 — AIRIS
- K961174 — ECG MONITOR MODEL DS-3130/3140
- K960181 — VERSION 3.7 OPERATING SYSTEM SOFTWARE
- K953248 — IRIS BILATERAL TMJ
- K953262 — QD BILATERAL BREAST COIL
- K953918 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- K945155 — AIRIS
- K943798 — MRH-1500
- K945386 — STRATIS
- K943800 — 2D,3D, TOF MR ANGIOGRAPHY
- K943799 — VERSION 5 OPERATING SYSTEM SOFTWARE
- K943321 — QUAD PELVIS COIL
- K942560 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- K940602 — EXTRA LARGE QUAD FLEX SPINE COIL
- K915403 — DIAGNOSTIC ULTRASOUND SYSTEM
- K935670 — VERSION 3 OPERATING SYSTEM SOFTWARE
- K935671 — 2D, 3D TOF MR ANGIOGRAPHY
- K935664 — FAST SPIN ECHO
- K934485 — HITACHI MPR-5000 & MPR-7000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MODIFICATION
- K934719 — EXTRA LARGE QUAD FLEX SPINE COIL
- K934212 — FAST SPIN ECHO
- K933645 — ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000
- K922846 — MRH-1500
- K926397 — FAST SPIN ECHO MEASURING FUNCTION
- K925009 — 2D TOF ANGIOGRAHY MEASURING FUNCTION
- K923140 — MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL
- K924126 — EUB-405
- K923010 — MAGNETIC RESONANCE DIAGNOSTIC DEVICE
- K920441 — 3D TOF ANGIOGRAPHY MEASURING FUNCTION
- K920159 — MOBILE MRP-7000
- K911993 — MRH-500
- K914263 — MRP-5000 & MRP-7000 HS/MR QUADRATURE KNEE COILS
- K914019 — MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)
- K911642 — MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION
- K911667 — HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.