DEVICE DETAILS
| NAME OF DEVICE | HM70 EVO DIAGNOSTIC ULTRASOUND APPARATUS |
|---|---|
| ESTABLISHMENT NAME | LAC MEDICAL SUPPLIES SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB2875122-101601 |
| BRAND NAME | SAMSUNG MEDISON |
| MEDICAL DEVICE CATEGORY | MD 1202 - Imaging devices utilising non-ionizing radiation |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | HM70 EVO is a general purpose, portable, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Color Doppler mode, Power Doppler mode, PW Spectral Doppler mode, CW Spectral Doppler mode, TDI mode, TDW mode, ElastoScan mode, 3D/4D imaging mode or as a combination of these modes. The HM70 EVO also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HM70 EVO has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The various models of transducers are available and the one probe port of system can be connected. The three probe ports of cart optionally may be connected at the same time. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. |
| DEVICE INTENDED PURPOSE | The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular. Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel and Lung. |
| VALIDITY DATE OF REGISTRATION | 18/08/2022 - 17/08/2027 |