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510(k) Data Aggregation

    K Number
    K222174
    Device Name
    RadioLens v1.0
    Manufacturer
    Date Cleared
    2023-03-28

    (250 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Synapsica

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    RadioLens v1.0 software is a medical diagnostic application that displays, processes, stores, and transfers DICOM data, with the exception of mammography. It provides the capability to store images and patient information, perform filtering, digital manipulation, and quantitative measurements. The client software is designed to run on standard personal and business computers. RadioLens v1.0 includes an optional SpindleX module which is used to analyze potential vertebral body displacements in spine, either absolute or relative, using cervical/lumbar digital X-Rays of spine. A qualified medical practitioner may use the module to semi-automatically identify relevant spine anatomy and calculate vertebral displacement measurements. Measurements are then used to determine severity and location of any spinal ligament injurv leading to subluxation using criteria published in AMA Guides to The Evaluation of Permanent Impairment, 5th & 6th edition. SpindleX is meant for assistance with analysis of spinal ligament injury in the adult population (>18 years of age) as captured in stress x-rays. SpindleX is not meant for patients that have undergone surgery or other traumatic injury that result in distortion of spinal anatomy.
    Device Description
    RadioLens v1.0 is a medical image management and processing system for general human radiology reporting and provides a browser based interface for transfer of DICOM files from the scanning equipment to Synapsica's cloud server, for distribution to authorized users, including Radiologists. It also provides a worklist that keeps track of patient cases that the user needs to work on; a DICOM Viewer that allows users to view and analyze images in patient scan; and a report editor where the Radiologist can prepare the text report that goes back to the patient and referring provider. RadioLens v1.0 includes an optional SpindleX module. The SpindleX is an artificial intelligence (AI) module that works on digital stress x-rays of the spine and assists with clinical interpretation by a qualified Radiologist by automatically providing multiple relevant measurements in the spine. SpindleX is meant for assistance with analysis of spinal ligament injury in the adult population (>18 years of age) as captured in stress x-rays. SpindleX is not meant for patients that have undergone surgery or other traumatic injury that result in distortion of spinal anatomy. The following visualization, quantification, and reporting functionalities are provided by the software: Visualization - o 2D image review - Image navigation tools ● - Patient worklist ● Quantitative Analysis The subject device performs the following anatomical measurements: - Ruth Jackson's angle, - Ferguson's angle - Canal diameter ● - Displacement of L3 vertebrae ● - Vertebral offset 0 - Motion Segment Integrity, Translational & Angular . Reporting The subject device provides a detailed, objective report for stress of spine following standards set by American Medical Association (AMA). The report is pre-populated with annotated snapshots of digital x-ray scan of the spine generated by SpindleX. Relevant measurements, per the Quantitative Analysis discussed above, are provided along the annotated images. Once the report has been edited and finalized by the Radiologist, it can be downloaded in microsoft word or pdf format.
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