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510(k) Data Aggregation
K Number
K163528Device Name
HITACHI Supria Whole-body X-ray CT System Phase 3
Manufacturer
Hitachi Medical Systems America, Inc.
Date Cleared
2017-03-03
(77 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Hitachi Medical Systems America, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Supria system is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes.
The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the Supria 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.
Device Description
The Supria is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 16-detector technology. The system allows optimum clinical applications ranging from routine exams in response to the diversified circumstances in imaging whole body regions.
The Supria system uses 16-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 16 slices of data simultaneously. The Xray sub-system features a high frequency generator. X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles.
The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system.
The Supria system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.
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K Number
K162079Device Name
TRILLIUM Oval Head Coil 32
Manufacturer
HITACHI MEDICAL SYSTEMS AMERICA, INC.
Date Cleared
2016-09-16
(51 days)
Product Code
MOS
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TRILLIUM OVAL Head Coil 32 is a 32 channel recieve-only multiple array device used with the Hitachi TRILLIUM OVAL 3.0 Tesla systems for imaging of the head region that can be interpreted by a trained physician.
Device Description
The TRILLIUM OVAL Head Coil 32 is a receive-only device that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and/or curved cross-sectional images that display the internal structure of the head. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
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K Number
K161748Device Name
SUPRIA w/guideShot Option
Manufacturer
HITACHI MEDICAL SYSTEMS AMERICA, INC.
Date Cleared
2016-08-17
(54 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Supria system is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes.
The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA). Multi-planar reconstruction (MPR) and volume rendering.
Volume datasets acquired by the Supria 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.
Device Description
The SUPRIA is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 16-detector technology. The system allows optimum clinical applications ranging from routine exams in response to the diversified circumstances in imaging whole body regions.
The SUPRIA system uses 16-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 16 slices of data simultaneously. The X-rav sub-system features a high frequency generator. X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles.
The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system.
The SUPRIA system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.
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K Number
K160152Device Name
Trillium Oval V 5.1 MRI System
Manufacturer
HITACHI MEDICAL SYSTEMS AMERICA, INC.
Date Cleared
2016-05-20
(119 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TRILLIUM Oval MRI 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 system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine 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.
Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses:
T1, T2, proton density weighted imaging
Diffusion weighted imaging
MR Angiography
Image processing
Spectroscopy
Whole Body
Device Description
The TRILLIUM OVAL is a Magnetic Resonance Imaging System that utilizes a 2.9 Tesla superconducting magnet in a gantry design. The TRILLIUM OVAL has been designed to enhance clinical utility as compared to the ECHELON Oval by taking advantage of the stronger magnetic field and stronger gradient field and slew rate. There is no change in the system composition from the predicate device.
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K Number
K153547Device Name
ECHELON Oval V 5.1 MRI System
Manufacturer
Hitachi Medical Systems America, Inc.
Date Cleared
2016-03-31
(111 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
Hitachi Medical Systems America, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ECHELON Oval MRI 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 system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system 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 (TI), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
Device Description
The ECHELON OVAL V5.1 is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. The design was based on the ECHELON MRI system. The ECHELON OVAL has been designed to enhance clinical utility as compared to the ECHELON by taking advantage of open architecture.
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K Number
K150595Device Name
SCENARIA Phase 3 Whole-body X-ray CT System
Manufacturer
HITACHI MEDICAL SYSTEMS AMERICA, INC.
Date Cleared
2015-10-30
(235 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SCENARIA Phase 3 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 Phase 3 can be post processed by the SCENARIA Phase 3 to provide additional information. Post processing capabilities included in the SCENARIA Phase 3 software include CT angiography (CTA), Multi-planar 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.
Device Description
The SCENARIA Phase 3 is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles. The system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories. The system uses 128-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 64 slices of data simultaneously. The X-ray sub-system features a high frequency generator, X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles. The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system.
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K Number
K150565Device Name
Supria Whole-body X-ray CT System
Manufacturer
HITACHI MEDICAL SYSTEMS AMERICA, INC.
Date Cleared
2015-09-30
(208 days)
Product Code
JAK
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Supria 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 Supria can be post processed by the system to provide additional information and can be transferred to external devices via a DICOM standard interface.
Post processing capabilities included in the Supria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.
The device output can provide an aid to diagnosis when used by a qualified physician.
Device Description
The Supria is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 16-detector technology. The system allows optimum clinical applications ranging from routine exams in response to the diversified circumstances in imaging whole body regions.
The Supria system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.
Ask a Question
K Number
K151015Device Name
ECHELON Oval V 5.0 MRI System
Manufacturer
HITACHI MEDICAL SYSTEMS AMERICA, INC.
Date Cleared
2015-07-29
(104 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ECHELON Oval 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 system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system 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.
Device Description
The ECHELON OVAL is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. The design was based on the ECHELON MRI system. The ECHELON OVAL has been designed to enhance clinical utility as compared to the ECHELON by taking advantage of open architecture.
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K Number
K143537Device Name
Sirius Starmobile tiara
Manufacturer
HITACHI MEDICAL SYSTEMS AMERICA, INC.
Date Cleared
2015-03-06
(81 days)
Product Code
IZL
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mobile X-ray Unit Sirius Starmobile tiara is a general radiography system and is composed of the X-ray high voltage generator, X-ray tube, support unit, and digital radiograph device (DR-ID 800) made by Fujifilm Corporation.
This device is designed for pediatric and adult patients.
It is intended for use in general radiography of the head, body, or extremities including pediatric exams. The device output can provide an aid to diagnosis when used by a qualified physician.
Device Description
The Sirius Starmobile tiara battery powered, mobile x-ray system features a built-in Flat Panel Detector System: DR-ID800 which is a modification of the FDR D-EVO Flat Panel Detector System (DR-ID600), K132509. Because the Flat Panel Detector System is incorporated in the mobile equipment, the images are available to the technologist in a very short time, allowing the technologist to assure the exam has been performed adequately, minimizing return trips. Wireless communication is available, as an option, for updates to the patient worklist from the RIS/HIS.
The Sirius Starmobile tiara provides smooth and quiet motorized travel capability via rear wheels independently driven by dual motors, a versatile radiography range through the pantograph arm, and easy-to-operate positioning of flat detector providing sharp image quality with a short exam completion time.
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K Number
K142734Device Name
TRILLIUM Oval MR System
Manufacturer
HITACHI MEDICAL SYSTEMS AMERICA, INC.
Date Cleared
2015-03-02
(160 days)
Product Code
LNH
Regulation Number
892.1000Why did this record match?
Applicant Name (Manufacturer) :
HITACHI MEDICAL SYSTEMS AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TRILLIUM Oval MRI System is an imaging device, and is intended to provide the physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system 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.
Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses: T1, T2, proton density weighted imaging, Diffusion weighted imaging, MR Angiography, Image processing, Spectroscopy, Whole Body
Device Description
The TRILLIUM OVAL is a Magnetic Resonance Imaging System that utilizes a 2.9 Tesla superconducting magnet in a gantry design. The design was based on the ECHELON Oval MRI system. The TRILLIUM OVAL has been designed to enhance clinical utility as compared to the ECHELON Oval by taking advantage of the stronger magnetic field and stronger gradient field and slew rate.
Ask a Question
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