Hitachi Medical Systems America, Inc.
FDA 510(k) medical device clearances.
Top product codes for Hitachi Medical Systems America, Inc.
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.