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510(k) Data Aggregation

    K Number
    K192629
    Device Name
    Spinalytics
    Manufacturer
    Optima Health Solutions International Corp.
    Date Cleared
    2019-12-21

    (89 days)

    Product Code
    LXM
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Optima Health Solutions International Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KKT device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the patient. The procedure involves the use of diagnostic imaging that quantifies the misalignment of vertebrae. The treatment is then administered using the KKT device to deliver impulses at a precise vector. Spinalytics is a software application which facilitates treatment using the KKT device. Spinalytics provides an interface to manage the patient information stored in a central database. Spinalytics facilitates measuring angles and distances of relevant sketal structures in a patient, by providing the practitioner with an interface to mark the position of these structures directly on digitized X-Rays. Spinalytics then calculates standard treatment protocol parameters which can be sent directly to the KKT device. Spinalytics is an optional accessory to the KKT device and does not change the intended use of the device.
    Device Description
    Spinalytics Application is an optional software accessory to the KKT device which facilitates the calculation of the treatment parameters, which were previously calculated manually. Qualified personnel may generate, review, verify, approve, print and export the treatment plan prior to patient treatment. Spinalytics Application also communicates directly with the KKT Device to seamlessly enter the treatment parameters into the device. The clinicians may still enter their own parameters in the Spinalytics Application which meet their own treatment and clinical protocols, if they choose. The Spinalytics Application software is installed on a computer near the KKT Device. It can be installed on any commercial grade PC that meets the minimum hardware and operating system requirements. The computer and the KKT Device communicate over a USB cable.
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