Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K242116
    Device Name
    EyeBOX EBX-4.1
    Manufacturer
    Oculogica, Inc.
    Date Cleared
    2025-04-04

    (259 days)

    Product Code
    QEA
    Regulation Number
    882.1455
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oculogica, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion. A negative BOX Score classification may correspond to eye movement that is consistent with a lack of concussion within one week of injury. A positive BOX Score classification corresponds to eye movement that may be present in both patients with or without concussion within one week of injury. The EyeBOX provides a set of eye-tracking metrics in relation to a reference database of uninjured individuals.
    Device Description
    Oculogica's EyeBOX EBX-4.1 is an eye-tracking device with custom software. The device is comprised of a host PC with integrated touchscreen interface for the operator, eye tracking camera, LCD stimulus screen and head-stabilizing rest (chin rest and forehead rest) for the patient, and data processing algorithm. The data processing algorithm detects subtle changes in eye movements resulting from concussion. The eye tracking task takes about 4 minutes to complete and involves watching a video move around the perimeter of a screen positioned in front of the patient while a high speed near-infrared (IR) camera records gaze positions 500 times per second. The post-processed data are analyzed automatically to produce one or more outcome measures. The device contains a rechargeable battery, which makes it possible to use without a direct connection to an active power source. The device has Wi-Fi and Ethernet capabilities, which optionally can provide the user with the ability to upload scans to a remote server, provide over-the-air software updates, and assist with customer support.
    Ask a Question
    K Number
    K212310
    Device Name
    EyeBOX (Model EBX-4)
    Manufacturer
    Oculogica, Inc.
    Date Cleared
    2021-12-22

    (152 days)

    Product Code
    QEA
    Regulation Number
    882.1455
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oculogica, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion. A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion. A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion.
    Device Description
    Oculogica's EyeBOX model EBX-4 uses eye-tracking technology and a data processing algorithm to detect subtle changes in eye movements resulting from concussion. The eye tracking task takes about 4 minutes to complete and involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high speed near-infrared (IR) camera, positioned just below the screen, records eye movements. The data are then analyzed to produce one or more outcome measures. The patient sits in front of the device with their head secured in a chinrest about 40 cm from the middle of the display. A face tracking camera, positioned above the screen, assists the patient and operator with proper placement of the patient by providing a second set of eye coordinates in three-dimensional space to calculate the patient's distance from the screen and the patient face's position relative to the display. The device contains a rechargeable battery, which makes it possible to use without a direct connection to an active power source. The device has Wi-Fi and Ethernet capabilities, which optionally can provide the user with the ability to send reports to a remote printer and/or file storage location.
    Ask a Question
    K Number
    K201841
    Device Name
    EyeBOX
    Manufacturer
    Oculogica, Inc.
    Date Cleared
    2020-09-06

    (66 days)

    Product Code
    QEA
    Regulation Number
    882.1455
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oculogica, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion. A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion. A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion.
    Device Description
    Oculogica's EyeBOX is an eye-tracking device with custom software. The device is comprised of a host PC with integrated touchscreen interface for the operator, eye tracking camera, LCD stimulus screen and head-stabilizing rest (chin rest and forehead rest) for the patient, and data processing algorithm. The data processing algorithm detects subtle changes in eye movements resulting from concussion. The eye tracking task takes about 4 minutes to complete and involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high speed near-infrared (IR) camera records gaze positions 500 times per second. The post-processed data are analyzed automatically to produce one or more outcome measures.
    Ask a Question
    K Number
    K191183
    Device Name
    EyeBOX
    Manufacturer
    Oculogica, Inc.
    Date Cleared
    2019-07-31

    (90 days)

    Product Code
    QEA
    Regulation Number
    882.1455
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oculogica, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion. A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion. A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion.
    Device Description
    Oculogica's EyeBOX is an eye-tracking device with custom software. The device is comprised of a host PC with integrated touchscreen interface for the operator, eye tracking camera, LCD stimulus screen and head-stabilizing rest (chin rest and forehead rest) for the patient, and data processing algorithm. The data processing algorithm detects subtle changes in eye movements resulting from concussion. The eye tracking task takes about 4 minutes to complete and involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high speed near-infrared (IR) camera records gaze positions 500 times per second. The post-processed data are analyzed automatically to produce one or more outcome measures.
    Ask a Question
    K Number
    DEN170091
    Device Name
    EyeBOX
    Manufacturer
    Oculogica, Inc.
    Date Cleared
    2018-12-28

    (371 days)

    Product Code
    QEA
    Regulation Number
    882.1455
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oculogica, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EveBOX is intended to measure and analyze eve movements as an aid in the diagnosis of concussion within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion. A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion. A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion.
    Device Description
    The Oculogica EyeBOX system consists of an integrated stand, eye-tracking camera, video stimulus display screen, and computer programmed for analysis of eye movements. It is intended to detect abnormal eye movement that may be related to a concussion. The device measures gaze, calculates a score on a 0-20 scale based on these measurements, and displays an EyeBOX classification based upon whether the scale value is above 10 or not. Scale values of 10 or more yield a positive EyeBOX classification, while scale values under 10 yield a negative EyeBOX classification.
    Ask a Question

    Page 1 of 1