DEVICE DETAILS
| NAME OF DEVICE | DIAGNOSTIC ULTRASOUND APPARATUS V SERIES |
|---|---|
| ESTABLISHMENT NAME | LAC MEDICAL SUPPLIES SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB2572122-95534 |
| BRAND NAME | SAMSUNG MEDISON CI., LTD |
| MEDICAL DEVICE CATEGORY | MD 1202 - Imaging devices utilising non-ionizing radiation |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The V8/V7/V6 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode. The V8/V7/V6 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 V8/V7/V6 has 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 fluid. 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 and Peripheral vessel. |
| VALIDITY DATE OF REGISTRATION | 20/06/2022 - 19/06/2027 |