DEVICE DETAILS
| NAME OF DEVICE | HS70A |
|---|---|
| ESTABLISHMENT NAME | LAC MEDICAL SUPPLIES SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB3997822-105278 |
| BRAND NAME | SAMSUNG |
| MEDICAL DEVICE CATEGORY | MD 1202 - Imaging devices utilising non-ionizing radiation |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | The HS70A 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, M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (realtime 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HS70A 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 HS70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The various transducers including linear array, curved linear array, endocavity, phased array and pencil array are available and any four (basic) or five (option) including one CW probe port may be connected at the same. 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. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. The HS70A uses digital multi-beam forming technology, and supports a variety of Linear, Convex, Phased, Volume and CW probes for a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 1.0 MHz to 20.0 MHz. These probes can be applied to a variety of clinical applications such as Fetal/Obstetrics (includes infertility monitoring of follicle development), Abdominal, Gynecology, Intra-operative, Pediatric, Small Organs, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel. |
| DEVICE INTENDED PURPOSE | Ultrasound diagnostic system and probes were designed for obtaining ultrasound images and analyzing human blood. 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 | 26/09/2022 - 25/09/2027 |