Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K133719
    Device Name
    PDE-NEO
    Manufacturer
    HAMAMATSU PHOTONICS, K.K.
    Date Cleared
    2014-03-27

    (112 days)

    Product Code
    IZI, OWN
    Regulation Number
    892.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAMAMATSU PHOTONICS, K.K.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pde-neo is an imaging system used in capturing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, micro-, reconstructive, and organ transplant surgeries.
    Device Description
    The pde-neo is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, micro-, reconstructive, and organ transplant surgeries. The pde-neo is intended for intraoperative visual assessment of blood vessels and related tissue perfusion by enabling surgeons to observe fluorescent images of blood vessels and related tissue perfusion. Indocyanine green (ICG) is injected intravenously into patients. Infrared light-emitting diodes (LEDs) are used to excite the fluorescence of ICG and illuminate the regions of a patient's anatomy to be observed. A charge coupled device (CCD) camera captures the fluorescent image that is used to assess the blood vessels and related tissue perfusion. The pde-neo consists of the following components: Camera Unit, Controller, and Remote Controller. The Camera Unit contains a CCD camera and LED light sources and is used either by hand or attaching it to a mechanical arm. The Controller receives the video signal of the fluorescent image from the Camera Unit and outputs the processed fluorescent image to the external video monitor and recorder. Adjustments of the fluorescent image are possible either by the Camera Unit or the Remote Controller.
    Ask a Question
    K Number
    K110480
    Device Name
    PDE PHOTODYNAMIC EYE
    Manufacturer
    HAMAMATSU PHOTONICS, K.K.
    Date Cleared
    2012-01-13

    (329 days)

    Product Code
    OWN, IZI
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    HAMAMATSU PHOTONICS, K.K.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PDE is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, micro-, reconstructive and organ transplant surgeries.
    Device Description
    The PDE is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, micro-, reconstructive and organ transplant surgeries. The PDE is intended for intraoperative visual assessment of blood vessels and related tissue perfusion, by enabling surgeons to observe fluorescent images of blood vessels and related tissue perfusion. Indocyanine green (ICG) is injected intravenously into patients. Infrared light-emitting diodes (LEDs) are used to excite the fluorescence of ICG and illuminate the regions of a patient's body to be observed. A charge coupled device (CCD) camera captures the fluorescent image that is used to assess the blood vessels and related tissue perfusion. The PDE consists of the following components: Camera Unit, Controller, and Remote Controller. The Camera Unit contains a CCD camera and LED light sources and is used either by hand or attaching it to a mechanical arm. The Controller receives the video signal of the fluorescent image from the Camera Unit and outputs the processed fluorescent image to the external video monitor and recorder. Adjustments of the fluorescent image are possible either by the Camera Unit or the Remote Controller.
    Ask a Question
    K Number
    K982171
    Device Name
    HAMAMATSU PET SCANNER, MODEL SHR-22000
    Manufacturer
    HAMAMATSU PHOTONICS, K.K.
    Date Cleared
    1998-09-17

    (90 days)

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

    HAMAMATSU PHOTONICS, K.K.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hamamatsu PET Scanner Model SHR-22000 is indicated for the imaging of the distribution in the body of physiological tracer molecules labeled with positron-emitting isotopes. Such images are particularly useful in the assessment of brain function.
    Device Description
    The Hamamatsu PET Scanner Model SHR-22000 is similar to previous PET scanners marketed by other companies, but it represents an increase in performance over other PET Scanners through improved resolution. The system was developed in a joint venture with Hitachi Medical Corporation (HMC). HMC provided the imaging workstation, patient table, and user interface, adapted from its nuclear medicine imaging workstation. The SHR-22000 PET Scanner system consists of five main subsystems: the main gantry with the detector arrays, the signal processing unit, the data acquisition unit, the patient table and positioning sub-system, and the imaging workstation and user interface. Model SHR-22000 has almost 22000 scintillator segments in its detector arrays, providing very fine resolution. The gantry also has a 6Ge-6Ga source mounted in a stainless steel rod for calibration.
    Ask a Question

    Page 1 of 1