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/2021/000233_3b92bcf03d066e726dc2edd47ff8301a_f7306f6f7e3da2ea4097d759ae5af1c8. This device is marketed under the brand name Revolution Discovery CT. 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 Discovery CT
License Holder
Wipro GE Healthcare Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The 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, including Axial, Cine, Helical (Revolution Discovery CT), Cardiac, Spectral, and Gated acquisitions for all ages. 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 for both single kV acquisitions and with fast kV switching spectral imaging option (Revolution Discovery CT)
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