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510(k) Data Aggregation

    K Number
    K994026
    Device Name
    EUB-6000 ULTRASOUND DIAGNOSTIC SCANNER
    Manufacturer
    HITACHI MEDICAL CORP. OF AMERICA
    Date Cleared
    2000-03-29

    (124 days)

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

    HITACHI MEDICAL CORP. OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: General (Track I only) Specific (Tracks I & III) Ophthalmic Fetal Abdominal Intra-operative (Spec.) Intra-operative (Neuro.) Laparoscopic Pediatric Small Organ (Spec.) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skel. (Convent.) Musculo-skel. (Superfic.) Intra-luminal Other (spec.) Cardiac Adult Cardiac Pediatric Trans-esophageal (card.) Other (spec.) Peripheral vessel Other (spec.)
    Device Description
    The Hitachi EUB-6000 Ultrasound Diagnostic Scanner is a Track 3 diagnostic ultrasound pulsed Doppler and pulsed echo imaging system capable of the following operating modes: B (including harmonic imaging), M, Pulsed and Continuous Doppler, and Color Flow (including Amplitude Doppler). It is intended for general ultrasound imaging of the human body, with specific uses under the general applications of cardiac, peripheral vessel, and fetal imaging and other.
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    K Number
    K991535
    Device Name
    CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
    Manufacturer
    HITACHI MEDICAL CORP. OF AMERICA
    Date Cleared
    1999-07-30

    (88 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    HITACHI MEDICAL CORP. OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended uses of Convergence™ CDR®M for Hitachi SPECTRADigital™V250DSP Gameras is identical to the principle of coincidence imaging used by EPIC-MCD Cleared under K952684, ADAC MCD-AC cleared under K971980 in intended use, methods, reconstruction algorithms, transmission source type, and effectiveness of application. These include: - Acquisition of patient specific biodistribution of positron-emitting radioisotopes in-vivo. - Acquisition of patient specific anatomic density via transmission imaging to determine attenuation coefficients applicable to emission slice data. - Reformation of coincidence data to images frames with subsequent reconstruction of transmission and Wholebody ECT data via FBP and/or ML-EM/OSEM reconstruction methods. - Analysis and generation of attenuation maps and coefficients to apply to emission ECT slice/volume sets. Convergence sm for for Hitachi with Imaging capabilities SPECTRADigital™ V250DSP Gamma Cameras option include: - All SPECT procedures in common practice including matrix based spatial framed, temporal/spatial list mode and angular projection mode static, gated and multi-orbit sampling - Use in conjunction with FDA approved 511 keV emitting radiopharmaceuticals - High and normal count-rate dynamic and non-temporal ECT - In conjunction with Coincidence based imaging, the detector performance and NUA® acquisition and processing characteristics are available for non-uniform attenuation ECT, attenuation correction in CID and CID based ECT imaging. - Multiple window sampled imaging, including scatter correction via single, dual or plural window processing.
    Device Description
    CONVERGENCE®M CDR §™ for Hitachi SPECTRADigital™ V250DSP Gamma Cameras, cleared under K954129 is an Coincidence Imaging Device (CID) option that provides capability to acquire 511 keV coincidence events and form images in 1D, 2D and 3D modes of operation. With the addition of ATTCOR, non-linear scaled low energy transmission correction utilizing NUA88 submitted under K991318) mapping of anatomical information using external radioactive line source transmission with analysis of densities and assignment of patient specific attenuation coefficients to minimize distortion due to overlying tissue and undesired scattered photons. The device is a combination of hardware and software to provide detection, decoding, image formation with corrections and Whole body and tomographic reconstruction. When the system is equipped with thicker 5/8" crystals submitted under K991129, the V250DSP efficiency for 511 keV events is improved. The additional Hardware which consists of Aperture Grids with graded absorbers, high speed pre-amps with coincident signal timing, high speed decoding and correction circuitry and acquisition control software. 1-D framing at the camera system is provided and 2-D, 3-D frame formation via workstation based FORE (Fourier Rebinning) and OS-EM processes. When equipped with ATTCORSM, a single, non-moving line source holder equipped with shutter, special line source slat collimation to minimize patient exposure and axial scatter and non-linear scaling processing is provided. The software consists of FORE rebinning. OSEM iterative and/or FBP (Filtered Back-Projection) reconstruction, transmission acquisition control and coefficient determination in the correction to ECT slice data per NUASM submitted under K991318.
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    K Number
    K991318
    Device Name
    CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
    Manufacturer
    HITACHI MEDICAL CORP. OF AMERICA
    Date Cleared
    1999-06-18

    (60 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    HITACHI MEDICAL CORP. OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended uses of Convergences™ NUA® for Hitachi SPECTRADigital™ V250DSP Gamma Cameras is identical to the ADAC Vantage ExSPECT 2.1 cleared under K971878 in system function and operational software. These include: - Acquisition of patient specific anatomic density via transmission imaging to determine attenuation coefficients applicable to emission slice data. - Reconstruction of transmission and emission SPECT data via FBP and/or ML-EM/OSEM reconstruction methods - Analysis and generation of attenuation maps and coefficients to apply to emission SPECT slice/volume sets. The acquisition of SPECT is as cleared under SPECTRADigital™Series V250DSP system K954129, with addition of transmission acquisition protocols to produce images which depict anatomical density of a patient. The device is intended to provide an enhancement to the emission images acquired SPECTRADigital™ Series V250DSP by correcting for attenuation and scatter effects in the patient. When resulting images are interpreted by a trained physician, the information provided can be useful in the diagnosis determination. Hitachi capabilities with with with with and Convergence SM NUA SM for for lmaging SPECTRADigital™ V250DSP Gamma Cameras option include: - I All SPECT procedures in common practice including matrix based spatial framed, temporal/spatial list mode and angular projection mode static, gated and multi-orbit sampling - 트 High and normal count-rate dynamic and non-temporal SPECT - 트 In conjunction with additional options for Coincidence based imaging, the detector performance and NUA®ª acquisition and processing characteristics are available for non-uniform attenuation SPECT, attenuation correction in CID and CID based ECT imaging (these options are covered under separate and exclusive PMAs) - I Multiple window sampled imaging, including scatter correction via single, dual or plural window processing.
    Device Description
    Convergence 3M NUA 3M for Hitachi SPECTRADigital™ V250DSP Gamma Cameras is an optional Attenuation Correction Device (ACD) that provides capability to map anatomical information using external radioactive line source transmission, analyze densities and assign patient specific attenuation coefficients to minimize distortion caused by false information in the emission computer tomographic images due to overlying tissue and undesired scattered photons. The device is a combination of hardware and software to provide transmission, collimation, acquisition and analysis/correction of ECT data. The Hardware which consists of a single, non-moving line source holder equipped with shutter, special line source slat collimation to minimize patient exposure and axial scatter and fan beam collimation. The standard source is Gadolinium 153 (240.4d T1/2, 97.4~103.2 keV, while the system has been confirmed with Technetium 99m ( 6hr T1/2, 140.5 keV) and Cerium-139 (137.6d T1/2, 165.8 keV). The software consists of camera based transmission acquisition control and workstation based OSEM iterative and/or FBP (Filtered Back-Projection) reconstruction, coefficient determination and correction to ECT slice data. The system uses the same camera mechanical platform, table, collimators, electrical system and acquisition/system operating software cleared under K954129, with the addition of acquisition/processing sequences to correct for scatter and effects of attenuation. The acquisition of transmission and emission data is performed via fast sequential orbit acquisition to minimize effects of cross-spill and cross falk.
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    K Number
    K991129
    Device Name
    HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL
    Manufacturer
    HITACHI MEDICAL CORP. OF AMERICA
    Date Cleared
    1999-05-13

    (41 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    HITACHI MEDICAL CORP. OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SPECTRADigital™ Series V250DSP system with 5/8" crystal option are identical to the intended uses of the SPECTRADigital™Series V250DSP camera cleared under K954129 including acquisition of SPECT, planar, and wholebody imaging of all organ systems utilizing FDA approved radiopharmaceuticals in the energy range from 50 to 511 keV. When resulting images are interpreted by a trained physician, the information provided can be useful in the diagnosis determination. Imaging capabilities with the Thick Crystal (5/8") Nal(TI) option include: - All SPECT and Planar procedures in common practice including matrix based spatial framed, temporal/spatial list mode and angular projection mode static, gated and multi-orbit sampling - High and normal count-rate dynamic planar and SPECT - In conjunction with additional options for Coincidence and transmission based imaging, the detector performance and characteristics are available for non-uniform attenuation SPECT, attenuation correction in CID and CID based ECT imaging (these options are covered under separate and exclusive PMAs) - Multiple window sampled imaging, including scatter correction via single, dual or plural window processing.
    Device Description
    The SPECTRADigital™ series gamma camera systems are area detectors designed to detect gamma rays emitted from the decay of radioisotopes injected into a patient. The position of the decay is calculated (a ray from the event to the detector) by the system, and stored. The positions of a large number of decay events forms an electronic image of the location of the radioactive material. This image can be displayed on a CRT or transferred to photographic film for review. The collection of data at multiple detector positions allows three dimensional information to be obtained by tomographic means. The addition of thicker Nal(TI) crystals enhance efficiency of detection at higher energies with minimal loss of imaging performance over energy ranges used routinely.
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    K Number
    K981434
    Device Name
    EUP-OL334 LAPARASCOPICPROBE
    Manufacturer
    HITACHI MEDICAL CORP. OF AMERICA
    Date Cleared
    1998-07-27

    (97 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    HITACHI MEDICAL CORP. OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: Laparoscopic
    Device Description
    The Hitachi EUP-OL334 Laparoscopic Probe is a Track 3 diagnostic ultrasound transducer capable of the following operating modes: B, M., Pulsed Doppler, and Color Flow (including Amplitude Doppler). It is intended for laparoscopic clinical applications with the EUB-525, EUB-555, and EUB-8000 Hitachi Diagnostic Ultrasound Systems.
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    K Number
    K954220
    Device Name
    EUB-8000
    Manufacturer
    HITACHI MEDICAL CORP. OF AMERICA
    Date Cleared
    1997-05-07

    (604 days)

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

    HITACHI MEDICAL CORP. OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The Hitachi EUB-8000 Ultrasound Electronic Scanner is a Track 3 diagnostic ultrasound system capable of the following operating modes: B, M, Pulsed Doppler, Color Flow, and Continuous Wave Doppler. Probes available with the EUB-8000 are intended for the following general clinical uses: Abdominal, Cardiac, Intra-operative , Fetal, Pediatric, Small Organ, Peripheral Vascular, Biopsy, Transvaginal, Transvaginal, and Neonatal Cephalic. The EUB-8000 utilizes digital front-end electronics for detection of echo signals.
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    K Number
    K962308
    Device Name
    EUB-905
    Manufacturer
    HITACHI MEDICAL CORP. OF AMERICA
    Date Cleared
    1996-07-17

    (30 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    HITACHI MEDICAL CORP. OF AMERICA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The Hitachi EUB-905 Ultrasound Electronic Scanner is Track1 diagnostic ultrasound system capable of the following operating modes: B, B/M and M mode. Probes available with the EUB-905 are intended for the following general clinical uses: Abdominal, Cardiac, Intraoperative, Fetal, Pediatric, Small organ, Peripheral Vascular, Transrectal and Transvaginal.
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