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510(k) Data Aggregation

    K Number
    K143024
    Device Name
    CAS-One Liver
    Manufacturer
    CAScination AG
    Date Cleared
    2015-04-28

    (189 days)

    Product Code
    OEW
    Regulation Number
    882.4560
    Why did this record match?
    Product Code :

    OEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CAS-One Liver system is indicated for open liver surgical procedures where image guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.
    Device Description
    The CAS-One Liver system is indicated for open liver surgical procedures where image aujdance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia. It visualizes the position and pose of surgical instruments relative to a three-dimensional model of the patients liver in real-time.
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    K Number
    K101979
    Device Name
    EXPLORER LIVER (PASSIVE TRACKING)
    Manufacturer
    PATHFINDER THERAPEUTICS, INC.
    Date Cleared
    2011-02-09

    (210 days)

    Product Code
    OEW
    Regulation Number
    882.4560
    Why did this record match?
    Product Code :

    OEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Explorer ™ Liver --- Passive Tracking device is indicated for open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.
    Device Description
    The Explorer" Liver --- Passive Tracking is an image-guided surgery medical device specifically designed to aid physicians during open liver procedures. The device is capable of mapping the current surgical position of tracked instruments onto preoperative, patient-specific MRI or CT medical images. These images can then be used as a guide by the physician for more accurate localization of tumors and other surrounding anatomic structures during liver surgery. The Explorer™ Liver --- Passive Tracking system consists of eight (8) components which are listed below: - An image-guided surgery software platform installed on a personal computer (PC) (1) - (2) An optical position sensor --- the Polaris Spectra or Vicra that can accurately localize the tracked devices listed below in passive tracking mode - . A passive tracked abdominal reference (used for definition of coordinate and instrument calibration) - . A passive tracked Localization Pen Probe - . A passive tracked Laser Range Scanner (LRS) - Two passive tracked adapters (can be attached onto up to two rigid surgical instruments ● simultaneously and used for their localization in 3-D surgical space) - (3) An LCD display monitor.
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    K Number
    K093494
    Device Name
    LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM
    Manufacturer
    PATHFINDER THERAPEUTICS, INC.
    Date Cleared
    2010-03-30

    (140 days)

    Product Code
    OEW
    Regulation Number
    882.4560
    Why did this record match?
    Product Code :

    OEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Explorer™ Liver device is indicated for open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.
    Device Description
    The Explorer™ Liver system is an image-guided surgery medical device specifically designed to aid physicians during open liver procedures. The device is capable of mapping the current surgical position of tracked instruments onto preoperative, patient-specific MRI or CT medical images. These images can then be used as a guide by the physician for more accurate localization of tumors and other surrounding anatomic structures during liver surgery. The Explorer™ Liver system consists of six (6) components which are listed below: - An image-guided surgery software platform installed on a personal computer (PC) (1) - A three lens active-based optical position sensor that can accurately localize the tracked devices (2) listed below - A tracked adapter multi tool (used for localization of rigid surgical instruments and to (a) define 3-D surgical space) - A tracked laser range scanner (b) - A tracked Localization Probe (c) - An LCD display monitor. (3)
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    K Number
    K071063
    Device Name
    LINASYS
    Manufacturer
    PATHFINDER THERAPEUTICS, INC.
    Date Cleared
    2007-12-20

    (248 days)

    Product Code
    OEW
    Regulation Number
    882.4560
    Why did this record match?
    Product Code :

    OEW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Linasys device is indicated for open liver surgical procedures where imageguidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.
    Device Description
    The Linasys (Liver Navigation System) is an image-guided surgery medical device specifically designed to aid physicians during open liver procedures. The device is capable of mapping the current surgical position of tracked instruments onto preoperative, patient-specific MRI or CT medical images. These images can then be used as a guide by the physician for more accurate localization of tumors and other surrounding anatomic structures during liver surgery. The Linasys system consists of six (6) components which are listed below: (1) An image-guided surgery software platform installed on a personal computer (PC) (2) A three lens active-based optical position sensor that can accurately localize the tracked devices listed below (3) A tracked localization probe (4) A tracked fixed reference emitter used to define 3-D surgical space (5) A tracked laser range scanner (6) An LCD display monitor.
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