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/2021/000560_3b92bcf03d066e726dc2edd47ff8301a_c8118ddd1f41f4a6306d86ec36994ac6. This device is marketed under the brand name Revolution Maxima. 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 Maxima
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 Maxima), 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.
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