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510(k) Data Aggregation

    K Number
    K192686
    Device Name
    Revolution Maxima, Revolution Ace
    Manufacturer
    GE Hangwei Medical Systems Co.,Ltd.
    Date Cleared
    2019-10-24

    (28 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    GE Hangwei Medical Systems Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results. The system is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages. The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.
    Device Description
    The Revolution Maxima CT system is composed of a gantry, patient table, operator console, host computer, and power distribution unit (PDU), and interconnecting cables. The system also includes image acquisition and reconstruction hardware/software, general system software, accompanying documents, and associated accessories, interconnections. The Revolution Maxima system is an evolutionary configuration of the predicate Optima CT660 CT system (K131576). All of the hardware functionality is identical to the predicate, however, some hardware changes have been made that did not change the system's performance specifications such as the new liquid metal bearing tube for improved tube life and reliability, the upgraded DAS and detector to improve the manufacturability and lower electronic nosie for better low signal performace and thermal management. Identical to the predicate, Revolution Maxima generates cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions modes. Revolution Maxima's Intended Use and Indications for Use remain identical to those of the predicate device. The Revolution Maxima CT system is a head and whole body CT system incorporating the same basic fundamental operating principles and the same indications for use as the predicate device. It's materials and construction are identical to our existing marketed products. Revolution Maxima remains compliant with IEC 60601-1 Ed. 3.1 and associated collateral and particular standards, NEMA XR 25, XR 28, and 21 CFR Subchapter J performance standards. The accompanying documents also contain the information in support of IEC61223-3-5 Ed. 1.0 for acceptance testing. The performance and image quality specifications are identical/equivalent to the predicate. The gantry has a 70 cm bore with a maximum FOV of 50 cm. Available rotation speeds range from 0.35 to 2.0 seconds. Same as the predicate, the Revolution Maxima has three types of reconstruction methods available: FBP, ASiR, and ASiR-V (K133640). The performance of ASiR-V on Revolution Maxima is identical to that on the predicate Optima CT660. Revolution Maxima includes most of the available features on the current production predicate device Optima CT660. The new changes incorporated into Revolution Maxima are primarily addition of a few features found on other GE current production CT systems, e.g. updated newer ITE host computer, Digital Tilt as an alternative to the tilted gantry, improved metal artifacts reduction called Smart MAR and 1024x1024 Recon. Digital Tilt is a software reformatting of the reconstructed images so that they appear like those reconstructed from a tilted gantry. The smaller pixel sizes of 1024 Recon improves the spatial resolution which is useful in clinical applications that would benefit from increased spatial resolution, especially those applications where a large display field of view is desired to simultaneously image corresponding left/right anatomy for comparison (e.g. highresolution lungs, internal auditory canals). There are other unique changes for Revolution Maxima which includes new gantry covers with more aesthetic and modern industry design, new gantry display panel on two tablets with high resolution touchscreens, one on each side of the gantry for improved access and usability. These gantry display tablets replace the single display screen located at the top center of the gantry in the predicate device and host the web based user interface for a new and improved workflow called "Express mode" which seamlessly displays the related protocols associated with order information in the RIS
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