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 MFG/MD/2021/000124_3b92bcf03d066e726dc2edd47ff8301a_8ac2321f9ba1d124e6b232adb8ead111. This device is marketed under the brand name Revolution ACTs. The license holder is Wipro GE Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is Sub Zonal Bangalore.
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Brand Name
Revolution ACTs
License Holder
Wipro GE Healthcare Private LimitedDevice Class
Approving Authority
Sub Zonal Bangalore
Product Information
The system is intended to be used for head and whole body computed tomography. The GE Revolution ACTs Computed Tomography X-ray 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, patient for all ages, including Axial, Cine, Helical. 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 GE Revolution ACTs CT Scanner System is indicated for head, whole body, and vascular X-ray Computed Tomography applications. 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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