Computed Tomography - India CDSCO Medical Device Registration
Computed Tomography is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000173_3b92bcf03d066e726dc2edd47ff8301a_a5d6b622871becbbf0b0ae6366a08652. This device is marketed under the brand name Revolution Evo. The license holder is Wipro GE Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Revolution Evo
License Holder
Wipro GE Healthcare Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The system is intended to be used for head, whole body Computed Tomography applications. 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 (Revolution Evo), 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 support, 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.
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