Bone Density Analysis Software - Vietnam Registration 240000792/PCBB-HCM
Access comprehensive regulatory information for Bone Density Analysis Software in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loแบกi B medical device is registered under number 240000792/PCBB-HCM and manufactured by Alpha Intelligence Manifolds, Inc.. The authorized representative in Vietnam is CรNG TY TNHH QUALTECH CONSULTING.
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Device Details
Registration Details
240000792/PCBB-HCM
000.00.19.H29-240402-0008
"AIM" DeepXray Coxa
DeepXray Coxa
Technical Details
DeepXray Coxa is a medical device software (SaMD) designed to evaluate the bone density (BMD) of the proximal femur by using the digital before-and-after images of the hip or pelvic bone. The information obtained can be used by the doctor to assess the risk of bone fracture, combined with the criteria of the World Health Organization ("WHO"), and to compare the estimated BMD with the group of young adults (20-29 years old) and healthy individuals at the appropriate age to calculate the corresponding T-scores and Z-scores. It should not be used as a substitute for any evaluation of the patient or as the sole basis for diagnosis or confirmation of diagnosis.
Dates and Status
Apr 12, 2024