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510(k) Data Aggregation

    K Number
    K150069
    Device Name
    Fine Structure Analysis(fineSA)
    Date Cleared
    2015-05-22

    (129 days)

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

    Acuitas Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    fineSA software is intended for use as a non-invasive device that processes designated MR images using the 2-D pulse sequence incorporated on Siemens Medical 3T MAGNETOM systems running syngo MR software versions B17 and D13. This includes the Aera, Skyra, Avanto and Verio models. fineSA software generates reports that provide information about the structural features in bone. The MR data, in the form of spectra or spectral images, reflect the spacing of structural features at a scale of approximately 500 microns or larger.
    Device Description
    fineSA is a tool for the characterization of trabecular bone microarchitecture using magnetic resonance data. fineSA analyzes data acquired from a region of interest with a 2-D pulse sequence. The result is a spectrum that shows not chemical information, but the average spacing of the structural elements within the region of interest. fineSA provides the ability to identify repetitive structural features as small as 500 um. Compatible MRI scanners, acquire one-dimensional data along the length of a defined region of interest in the anatomical region using a standard pulse sequence available on the OEM scanner. The additional acquisition time required to collect the fineSA compatible data is less than 2 minutes. The resulting DICOM data object is transferred to a network personal computer loaded with fineSA software for processing and report generation. The DICOM input data is received from the MRI scanner via standard DICOM protocols. The processing performed is driven by the received data content, and at the completion of data processing and analysis, a PDF formatted report is generated and transferred to a designated DICOM destination as a DICOM encapsulated PDF document for viewing and interpretation. fineSA is a software only image processing system that can be installed on any network computer that meets the specified minimum hardware and operating system requirements. The system can be deployed on the radiology internal network or at a remote location with secure access to radiology internal network.
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