DEVICE DETAILS
| NAME OF DEVICE | DIAGNOSTIC ULTRASOUND APPARATUS RS85 PRESTIGE, RS80 EVO |
|---|---|
| ESTABLISHMENT NAME | LAC MEDICAL SUPPLIES SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB4792723-149386 |
| BRAND NAME | SAMSUNG MEDISON CO., LTD |
| MEDICAL DEVICE CATEGORY | MD 1202 - Imaging devices utilising non-ionizing radiation |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The RS85 and RS80 EVO are general purpose, mobile, software controlled, ultrasound scanner. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, ElastoScan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes. The RS85 and RS80 EVO also give 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 RS85 and RS80 EVO have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. |
| DEVICE INTENDED PURPOSE | The ultrasound diagnostic 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, Trans- esophageal (Cardiac) and Peripheral vessel. |
| VALIDITY DATE OF REGISTRATION | 27/09/2023 - 26/09/2028 |