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510(k) Data Aggregation

    K Number
    K210054
    Device Name
    Cios Spin
    Date Cleared
    2021-02-05

    (28 days)

    Product Code
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Siemens Medical Systems USA, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cios Spin is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
    Device Description
    The Cios Spin (VA30) mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Spin provides comprehensive image acquisition modes to support orthopedic and vascular procedures. The system consists of two major components: a) The C-arm with X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and be lifted vertically, shifted to the side and move forward/backward by an operator. b) The second unit is the image display station with a moveable trolley for the image processing and storage system, image display and documentation. Both units are connected to each other with a cable. The main unit is connected to the main power outlet and the trolley is connected to a data network.
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    K Number
    K181560
    Device Name
    Cios Alpha
    Date Cleared
    2018-10-24

    (132 days)

    Product Code
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Siemens Medical Systems USA, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro- intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
    Device Description
    The Cios Alpha mobile fluoroscopic C-arm X-ray System is designed for the surgical environment. The Cios Alpha provides comprehensive image acquisition modes. The system consists of two major components: a) The C-arm with an X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes and lifted vertically, shifted to the side and moved forward/backward by an operator. b) The second component is the image display station with a moveable trolley that holds the image processing and storage system, and the image display. Both components are connected to each other with a cable.
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    K Number
    K111861
    Device Name
    SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE
    Date Cleared
    2012-01-06

    (190 days)

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

    SIEMENS MEDICAL SYSTEMS USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    syngo.MR Oncology is a syngo.via-based image viewing, processing and reading software. This software allows for oncological MR image evaluation in a structured way. It is a reading application primarily for convenient reading of MR scans of single or multiple body regions up to the entire body which have been acquired for clinical purposes such as oncological screening, staging and grading. The reading application does not block the display of data from other modalities that syngo.via supports. syngo.MR Oncology is designed to support the oncological workflow including interpretation and evaluation of examinations, and follow-up documentation of findings. Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.MR Oncology is a tool to support the standard practices and visual comparisons. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.
    Device Description
    In addition to the reading and reporting functions/tools that are available in the predicate syngo.via basic software configuration, Siemens Healthcare intends to offer MR specific workflow configurations that are adapted for MR Oncology (syngo.MR Oncology). syngo.MR Oncology is a syngo-based image viewing, processing and reading software. This software allows for oncological MR image evaluation in a structured way. It is a reading application supporting convenient reading of MR scans of single or multiple body regions, up to the entire body which have been acquired for clinical purposes such as oncological screening, diagnosis and staging. The medical device software syngo.MR Oncology consists of the following two applications: syngo.MR Onco Workflows and the syngo.MR 3D Lesion Segmentation Tool. The syngo.MR Onco Workflow application consists of the following tools: MR Onco Multi-Region, MR Onco Liver, MR Onco Brain, MR Onco TimCT and an Onco report. The syngo.MR 3D Lesion Segmentation Tool also known as MR Segmentation tool, is a tool using the Random walker algorithm (default algorithm) or the Level Set algorithm. 3D Lesion Segmentation provides convenient volumetric evaluation of lesions and/or other structure of interest as well as a particularly useful tool for oncology applications (for example volumetric evaluation of tumors, lymph nodes and metastases), and nononcology lesions or other structures of interest with sufficient contrast to surrounding tissue.
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