About

This product is a software which used to read medical images and assist in analyzing bone density and osteoporosis. The medical images output by X-ray are converted into the aided analyzed medical image information, through the functions of image transmission, storage, reformatting, and display medical image information. This can assist physicians in diagnosing osteoporosis, judging the risk of fractures and other symptoms leading to low bone density.

＊Product performance, intended use or indications
By outputting bone mineral density (BMD), Z-score, T-score, T-score ≤ -2.5, and fracture risk assessment tool (FRAX), medical images are converted into aided analyzed medical image information that shows bone density and osteoporosis. In clinical risk evaluation, this product can allow physicians to diagnose whether there is a risk of fracture due to osteoporosis or other symptoms which caused the reduction of bone density. This product is unrestricted to be used for specific diseases, and is only restricted to analyze images of the patient's hip bone and femur area.

＊Note：
Implants in the body such as bone connectors, bone plates, etc., which may affect the results of bone density assessment.

＊This product can install to your X1 Imaging for FREE!

＊TFDA Certificate
Medical device Certificate No. ：衛部醫器製字第007409號
Medical device name："Biomedica" X1 Bone densitometer Solution
Registrant：Biomdcare Corporation
Registrant Address：Rm. 1A, 4 F., No. 23, Nanke 3rd Rd., Xinshi Dist., Tainan City 74147, Taiwan (R.O.C.)

＊Manufacturer
Name：Biomdcare Corporation
Address：Rm. 1A, 4 F., No. 23, Nanke 3rd Rd., Xinshi Dist., Tainan City 74147, Taiwan (R.O.C.)

＊Pharmaceutical company
Name：Biomdcare Corporation
Address：2 F., No. 11, Ln. 218, Sec. 2, Zhongxing Rd., Xindian Dist., New Taipei City 23146, Taiwan (R.O.C.)
License/Certificate No：新北府店衛藥販字第623105C730號
Consultation hotline：+886 2 8911-2168

＊Before use, please read the original manufacturer's manual and follow the instructions.