DEVICE DETAILS
| NAME OF DEVICE | EVO Q10 ULTRASOUND SCANNER EVO Q20 ULTRASOUND SCANNER EVO Q30 ULTRASOUND SCANNER |
|---|---|
| ESTABLISHMENT NAME | LAC MEDICAL SUPPLIES SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB7601126-232986 |
| BRAND NAME | SAMSUNG DIAGNOSTIC ULTRASOUND SYSTEM |
| MEDICAL DEVICE CATEGORY | MD 1202 - Imaging devices utilising non-ionizing radiation |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The EVO Q10, EVO Q20, EVO Q30 are general purpose, portable ultrasound scanner designed to deliver high-resolution imaging and advanced measurement capabilities across a wide range of clinical application. Controlled via software, the system supports a comprehensive suite of imaging modes including 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 and 4D Imaging Modes, ElastoScan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode as well as combinations of these modes. |
| 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, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Dermatology, Emergency, Trans-esophageal (Cardiac) and Peripheral vessel. |
| VALIDITY DATE OF REGISTRATION | 26/05/2026 - 25/05/2031 |