DEVICE DETAILS
| NAME OF DEVICE | HS30 , HS40, HS50, HS60 DIAGNOSTIC ULTRASOUND APPARATUS |
|---|---|
| ESTABLISHMENT NAME | LAC MEDICAL SUPPLIES SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB8706822-104178 |
| BRAND NAME | SAMSUNG MEDISON CO., LTD |
| MEDICAL DEVICE CATEGORY | MD 1202 - Imaging devices utilising non-ionizing radiation |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The HS30 and HS40 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 Mode, M Mode, PW Spectral Doppler Mode, CW Spectral Doppler Mode, TDI (Tissue Doppler Imaging) Mode, TDW (Tissue Doppler Wave) Mode, ElastoScan Mode, Freehand 3D mode, 3D/4D mode, Dual Mode, Quad Mode or as a combination of these modes. The HS30 and HS40 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 HS30 and HS40 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The HS50 and HS60 are a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color M mode, Anatomical mode, Color Doppler mode, Pulsed Wave (PW) Spectral Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan Mode, 3D/4D/XI STIC imaging mode, Dual mode, Quad mode, Combined mode, Simultaneous mode and Zoom mode. The HS50 and HS60 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 HS50 and HS60 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, |
| VALIDITY DATE OF REGISTRATION | 19/09/2022 - 18/09/2027 |