Comparing Performance with Predicative Device

The DDR Inventor-V is nearly same or similar in several characteristics as the Lodox Statscan, which has been sold in the world under FDA and CE approval. A difference between DDR Inventor-V and Lodox Statscan is detector adapted. The function of detector is receptor for digitizing the signal of incident radiation and its difference can not cause any side effect on the patient and the safety of the device has been proved with the test required by EN60601-1. Our decision is also based on the risk analysis report, related articles on journals. DDR Inventor-V is a device, which is intended to use for normal X-ray examinations as is currently practiced with general-purpose single short X-ray machines. We conclude that it is clinically safe and effective for user and patients with the intended use.