X-RAY - India CDSCO Medical Device Registration
X-RAY is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000124_f4e282193591ecee11e6f68e9c1173cf_333abd130759ac4d85f0cec8b1b10611. 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
Brivo XR115 mobile radiographic imaging system is designed to generate diagnostic radiographic X-rays that may be used to detect disease or injury early enough for a medical problem to be managed, treated or cured. X-rays are used in many types of examinations and procedures that include radiography to find orthopedic damage, tumors, pneumonia and foreign objects. The Brivo XR115 Mobile X-Ray systems is intended to take exposures utilizing film-based cassettes or Computed Radiography (Revolution ACTs) Cassette. The system is indicated for use on neonates, pediatric, adult and elderly patients for general purpose diagnostic radiographic examinations and procedures. Indicated use of the system is irrespective of gender, height and weight. The mobility of the system enables general-purpose radiographic procedures throughout the clinical environment, or as needed within the Emergency, Intensive care (Revolution ACTs), Neonatal Intensive Care Unit, Cardiac and Operating departments, for patients who have limited mobility or in cases where it is unsafe or impractical to move them to a traditional RAD room. The Brivo XR115 is indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts with the patient sitting, standing, or lying in prone or supine position.
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