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510(k) Data Aggregation

    K Number
    K233391
    Device Name
    cCeLL - In vivo
    Manufacturer
    VPIX Medical, Inc.
    Date Cleared
    2024-08-21

    (324 days)

    Product Code
    GWG, KAR, OWN
    Regulation Number
    882.1480
    Why did this record match?
    Applicant Name (Manufacturer) :

    VPIX Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The cCeLL - In vivo is an optic scanner probe placed in direct contact with tissue to create images of the internal microstructure of tissues and is indicated for use with indocyanine green (ICG) for fluorescence imaging as an aid in the visualization of vessels (micro- and macro-vasculature) blood flow in the cerebrovasculature before, during or after cranial diagnostic and therapeutic procedures, such as tumor biopsy and resection.
    Device Description
    The cCeLL - In vivo is used to provide real-time endoscopic images of near-infrared (NIR) indocyanine green (ICG) dye fluorescence during minimally invasive, neurosurgery in adults. The overall system includes a 6 mm Pixection ICG/NIR Endoscope (0°) for use in neurosurgery, a light source for emission of NIR illumination, a photo-multiplier tube capable of capturing NIR imaging, and a sterile probe sheath intended for maintaining a sterile barrier between the subject device and the patient. The cCeLL - In vivo can be used with any medical grade high definition (HD) monitor with a DVI-D or RGB input. The patient contacting components contact tissue or bone with a duration of less than 24 hours.
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