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510(k) Data Aggregation

    K Number
    K163528
    Device 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
    892.1750
    Why 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
    K162079
    Device Name
    TRILLIUM Oval Head Coil 32
    Manufacturer
    HITACHI MEDICAL SYSTEMS AMERICA, INC.
    Date Cleared
    2016-09-16

    (51 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why 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
    K161748
    Device Name
    SUPRIA w/guideShot Option
    Manufacturer
    HITACHI MEDICAL SYSTEMS AMERICA, INC.
    Date Cleared
    2016-08-17

    (54 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why 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
    K160152
    Device 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
    892.1000
    Why 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
    K153547
    Device 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
    892.1000
    Why 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
    K150595
    Device 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
    892.1750
    Why 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
    K150565
    Device 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
    892.1750
    Why 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.
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    K Number
    K151015
    Device 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
    892.1000
    Why 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
    K143537
    Device Name
    Sirius Starmobile tiara
    Manufacturer
    HITACHI MEDICAL SYSTEMS AMERICA, INC.
    Date Cleared
    2015-03-06

    (81 days)

    Product Code
    IZL
    Regulation Number
    892.1720
    Why 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
    K142734
    Device Name
    TRILLIUM Oval MR System
    Manufacturer
    HITACHI MEDICAL SYSTEMS AMERICA, INC.
    Date Cleared
    2015-03-02

    (160 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why 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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