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510(k) Data Aggregation

    K Number
    K211406
    Device Name
    OASIS MRI System
    Manufacturer
    Hitachi Healthcare Americas
    Date Cleared
    2021-10-07

    (154 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hitachi Healthcare Americas

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OASIS 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 (T), 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 OASIS is a Magnetic Resonance Imaging System that utilizes a 1.2 Tesla superconducting maqnet in a qantry design.
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    K Number
    K202422
    Device Name
    Arietta 65
    Manufacturer
    Hitachi Healthcare Americas
    Date Cleared
    2020-11-04

    (72 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hitachi Healthcare Americas

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This ARETTA 65 is intended for use in a Healthcare facility (hospital, private medical office, etc.) by Healthcare trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculoskel. (Superfic.), Other (spec.) -Gynecological, Other (spec.) - Wound, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, clinical applications. The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Dopler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.
    Device Description
    The ARIETTA 65 is a multi-functional ultrasound diagnostic scanner in which Doppler. Color Flow Mapping, etc. are provided and all circuits related to image quality are fully digitalized. This device can be utilized with linear, convex, radial and phased array scan type probes for usage with a variety of clinical applications. The ARIETTA 65 can be used for individual or combined display in the image display model listed below. - B mode is a display mode in which the tomographic imaqe is formed with plural . ultrasound beams by the methods mentioned above. During the process of creating the tomographic image, adaptive filters (HI REZ) that modify the characteristics of each echo filter are used to produce a clear image. - M mode is a display mode of ultrasound beams received sequentially and repeatedly on ● the screen from the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale. - There are two types of D (Doppler) mode: PW Doppler mode and CW Doppler mode. ● PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method. - Color Doppler mode receives ultrasound from the same direction and detects any . changes that occur over time to identify three types of bloodstream information: its direction, its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode, Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need. The 4 methods of electronic scanning are as follows. - Linear Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject. - Convex Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject. - . Sector Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject. - . Trapezoidal Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the patient.
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    K Number
    K202030
    Device Name
    OASIS MRI System
    Manufacturer
    Hitachi Healthcare Americas
    Date Cleared
    2020-10-21

    (91 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hitachi Healthcare Americas

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OASIS 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-latice 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 OASIS is a Magnetic Resonance Imaging System that utilizes a 1.2 Tesla superconducting maqnet in a qantry design.
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    K Number
    K200498
    Device Name
    SCENARIA View
    Manufacturer
    Hitachi Healthcare Americas
    Date Cleared
    2020-07-17

    (140 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hitachi Healthcare Americas

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SCENARIA View system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The SCENARIA View system can also be used for interventional needle guidance. Volume datasets acquired by a SCENARIA View system can be post-processed in the SCENARIA View system to provide additional information. Post-processing capabilities of the SCENARIA View software include, multi-planar reconstruction (MPR), and volume rendering. Volume datasets acquired by a SCENARIA View system can be transferred to external devices via a DICOM standard interface. The Low Dose CT Lung Cancer Screening Option for the SCENARIA View system is indicated for using low dose CT for lung cancer screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or Hitachi.
    Device Description
    The SCENARIA View is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles. The SCENARIA View 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. The SCENARIA View system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.
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    K Number
    K192851
    Device Name
    OASIS MRI System
    Manufacturer
    Hitachi Healthcare Americas
    Date Cleared
    2020-02-21

    (141 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hitachi Healthcare Americas

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OASIS 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 (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 OASIS is a Magnetic Resonance Imaging System that utilizes a 1.2 Tesla superconducting maqnet in a qantry design.
    Ask a Question
    K Number
    K190841
    Device Name
    SCENARIA View
    Manufacturer
    Hitachi Healthcare Americas
    Date Cleared
    2019-09-13

    (165 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hitachi Healthcare Americas

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SCENARIA View system is indicated to acquire axial volumes of the whole body including the head. Images can be acquired in axial, helical, or dynamic modes. The SCENARIA View system can also be used for interventional needle guidance. Volume datasets acquired by a SCENARIA View system can be post-processed in the SCENARIA View system to provide additional information. Post-processing capabilities of the SCENARIA View software include, multi-planar reconstruction (MPR), and volume rendering. Volume datasets acquired by a SCENARIA View system can be transferred to external devices via a DICOM standard interface. The Low Dose CT Lung Cancer Screening Option for the SCENARIA View system is indicated for using low dose CT for lung cancer screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body, a professional medical society, and/or Hitachi.
    Device Description
    The SCENARIA View is a multi-slice computed tomography system that uses x-ray data to produce cross-sectional images of the body at various angles. The SCENARIA View 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. The SCENARIA View system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.
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    K Number
    K191233
    Device Name
    ARIETTA 750
    Manufacturer
    Hitachi Healthcare Americas
    Date Cleared
    2019-08-09

    (93 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hitachi Healthcare Americas

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ARIETTA 750 is intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel clinical applications.
    Device Description
    The ARIETTA 750 is a multi-functional ultrasound diagnostic scanner in which Doppler. Color Flow Mapping, etc. are provided and all circuits related to image quality are fully digitalized. This device can be utilized with linear, convex, radial and phased array scan type probes for usage with a variety of clinical applications. The ARIETTA 750 can be used for individual or combined display in the image display model listed below. - B mode is a display mode in which the tomographic imaqe is formed with plural ultrasound beams by the methods mentioned above. During the process of creating the tomographic image, adaptive filters (HI REZ) that modify the characteristics of each echo filter are used to produce a clear image. - M mode is a display mode of ultrasound beams received sequentially and repeatedly on the screen from the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale. - There are two types of D (Doppler) mode: PW Doppler mode and CW Doppler mode. PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method. - Color Doppler mode receives ultrasound from the same direction and detects any . changes that occur over time to identify three types of bloodstream information: its direction, its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode, Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need. The 5 methods of electronic scanning are as follows. - Linear Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject. - Convex Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject. - Sector Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject. - Radial Scanning Method: By this method, the ultrasound probe emits a 360 degree (radial) ultrasound beam and draws a tomographic image of the test subject. - Trapezoidal Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the patient.
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    K Number
    K190248
    Device Name
    ARIETTA 50
    Manufacturer
    Hitachi Healthcare Americas
    Date Cleared
    2019-04-02

    (54 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hitachi Healthcare Americas

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This ARIETTA 50 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), A Small Organ (Spec.), Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Other (Wound), Cardiac Adult, Cardiatric, Transesophageal (card.), Peripheral vessel, Other (Gynecological), clinical applications.
    Device Description
    The ARIETTA 50 is a multi-functional ultrasound diagnostic scanner in which Doppler. Color Flow Mapping, etc. are provided and all circuits related to image quality are fully digitalized. This device can be utilized with linear, convex, radial and phased array scan type probes for usage with a variety of clinical applications. The ARIETTA 50 can be used for individual or combined display in the image display model listed below. - B mode is a display mode in which the tomographic imaqe is formed with plural . ultrasound beams by the methods mentioned above. During the process of creating the tomographic image, adaptive filters (HI REZ) that modify the characteristics of each echo filter are used to produce a clear image. - M mode is a display mode of ultrasound beams received sequentially and repeatedly on ● the screen from the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale. - There are two types of D (Doppler) mode: PW Doppler mode and CW Doppler mode. ● PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method. - Color Doppler mode receives ultrasound from the same direction and detects any . changes that occur over time to identify three types of bloodstream information: its direction, its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode, Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need. The 4 methods of electronic scanning are as follows. - Linear Scanning Method: ● By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject. - . Convex Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject. - . Sector Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject. - . Trapezoidal Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the patient.
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    K Number
    K183291
    Device Name
    Supria True64 Whole-Body X-Ray CT System
    Manufacturer
    Hitachi Healthcare Americas
    Date Cleared
    2019-02-01

    (67 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hitachi Healthcare Americas

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Supria True64 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 True64 is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 64-detector technology. The system allows optimum clinical applications ranging from routine exams in response to the diversified circumstances in imaging whole body regions.
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    K Number
    K183456
    Device Name
    Aloka Arietta 850
    Manufacturer
    Hitachi Healthcare Americas
    Date Cleared
    2019-01-28

    (46 days)

    Product Code
    IYN, ITX, IYO
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hitachi Healthcare Americas

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ALOKA ARIETTA 850 is 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.
    Device Description
    The ALOKA ARIETTA 850 is a multi-functional ultrasound diagnostic scanner in which Doppler, Color Flow Mapping, etc. are provided and all circuits related to image quality are fully digitalized. This device can be utilized with linear, convex, radial and phased array scan type probes for usage with a variety of clinical applications. The ALOKA ARIETTA 850 can be used for individual or combined display in the image display model listed below. - B mode is a display mode in which the tomographic image is formed with plural ultrasound beams by the methods mentioned above. During the process of creating the tomographic image, adaptive filters (HI REZ) that modify the characteristics of each echo filter are used to produce a clear image. - M mode is a display mode of ultrasound beams received sequentially and repeatedly on the screen from the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale. - There are two types of D (Doppler) mode: PW Doppler mode and CW Doppler mode. PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method. - Color Doppler mode receives ultrasound from the same direction and detects any changes that occur over time to identify three types of bloodstream information: its direction, its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode. Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need. The 5 methods of electronic scanning are as follows. - Linear Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject. - Convex Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject. - Sector Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject. - Radial Scanning Method: By this method, the ultrasound beam emits a 360 degree (radial) ultrasound beam and draws a tomographic image of the test subject. - Trapezoidal Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the patient.
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