DEVICE DETAILS
| NAME OF DEVICE | U60 DIAGNOSTIC ULTRASOUND SYSTEM |
|---|---|
| ESTABLISHMENT NAME | ROCKY SCIENTIFIC INSTRUMENTATION |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB2604323-117884 |
| BRAND NAME | EDAN |
| MEDICAL DEVICE CATEGORY | MD 1202 - Imaging devices utilising non-ionizing radiation |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | The U60 is a portable Diagnostic Ultrasound System, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging, etc. Various image parameter adjustments, 15-inch LCD and diverse probes are configured to provide clear and stable images. The device is not incorporated medicinal substances, tissues or blood products. The device consists of a main unit and accessories, including transducers, needle guide brackets, ECG cable, etc. The diagnostic ultrasound system (U50/U60/U2) is applicable for adults, pregnant women, pediatric patients’ ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional. |
| DEVICE INTENDED PURPOSE | The diagnostic ultrasound system (U60) is applicable for adults, pregnant women, pediatric patients’ ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), endovaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional. |
| VALIDITY DATE OF REGISTRATION | 03/02/2023 - 02/02/2028 |