Magnetic Resonance Imaging - India CDSCO Medical Device Registration
Magnetic Resonance Imaging is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000124_301cad2a0f77cdfc28e4f33b693d4618_5f7263608962d241e847e83ca350f253. 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 systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis
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