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DynaWell® L-Spine
DynaWell® L-Spine, our first product, grew out of a need to scan spine disorders and lower back problems with greater accuracy. Designed for use on virtually any CT or MRI scanner, it simulates the axial compression on a patient's spine when standing. Lumbar spine scanning requires more planning than conventional chest and body scanning. The positioning of the patient and selection of an appropriate technique to fit the clinical indications are essential. In this respect, DynaWell L-Spine is a helpful diagnostic tool for any CT or MRI scanner, as it offers a comfortable, easy-to-use diagnostic technique that enhances the data acquired by the scanner. Problems that would ordinarily remain undetected when the patient's spine is relaxed are visible with the use of our unit. Published studies in, among others Spine, and ongoing studies verify that the DynaWell® methodology is valuable in lumbar spine pathology (spinal stenosis, sciatica, disc herniation, synovial cysts) and hip, knee and ankle pathology. The invention itself was made by a group of physicians at Sahlgrenska University Hospital in Gothenburg, who also documented the medical benefits scientifically.
See How It Works and Imaging Benefits for the full picture.
FDA Approval
On August 13, 1999, the US Food and Drug Administration ("FDA"), pursuant to the Company's 510(k) pre-market notification, approved DynaWell L-Spine for marketing. The product is classified in Regulatory Class: II 510(k) No. K992120. It has an indication for use as an accessory for axial compression of the lumbar spine in CT and MRI imaging for enhanced and more relevant diagnosis during research and clinical purposes.
CE Certificate
On March 14, 2000, the product obtained the CE-mark approval (Registration No. 41313339) in Europe, as a device for improved radiological diagnosis through compression of the spine with measuring functions.
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