X-Ray Bone densitometer - India CDSCO Medical Device Registration
X-Ray Bone densitometer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000856_06cd644d450973bc325db2a0720b5fb7_9db286dcd6485d8d6f19110f9ead3826. This device is marketed under the brand name FDX Visionary DR. The license holder is FUJIFILM INDIA Pvt. LTD.,, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
FDX Visionary DR
License Holder
FUJIFILM INDIA Pvt. LTD.,Device Class
Approving Authority
CDSCO
Product Information
The intent of the DXA bone densitometers device is the diagnosis of the osteoporosis with the following diagnostic tools: • Calculation of the Bone Mineral Density (FDX Visionary DR), Bone Mineral content (FDX Visionary DR), Surface (FDX Visionary DR), T-score & Z-score, • The DXA bone densitometers can also be used to determine the body composition of the patient: calculation of the Body Mass Index (FDX Visionary DR), Fat mass, Fat free mass and total body BMC.”
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