Vietnam MOH registration 240000792/PCBB-HCM

Bone Density Analysis Software

VN: Phần mềm phân tích mật độ xương

Vietnam·Risk Class TTBYT Loại B·"AIM" DeepXray Coxa·Alpha Intelligence Manifolds, Inc.·Registered Apr 12, 2024

Registration details

Analysis ID: 240000792/PCBB-HCM
Submission ID: 000.00.19.H29-240402-0008
Product Type: "AIM" DeepXray Coxa
Product Code: DeepXray Coxa

Company information

Manufacturer: Alpha Intelligence Manifolds, Inc.
Product Owner: Alpha Intelligence Manifolds, Inc.
Authorized Representative: CÔNG TY TNHH QUALTECH CONSULTING

Technical details

Intended Use: 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

Registration Date: Apr 12, 2024

About this record

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 Loại B medical device is registered under number 240000792/PCBB-HCM and manufactured by Alpha Intelligence Manifolds, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH QUALTECH CONSULTING.

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