DEVICE DETAILS
| NAME OF DEVICE | GR40CW |
|---|---|
| ESTABLISHMENT NAME | LAC MEDICAL SUPPLIES SDN BHD |
| REGISTRATION NO | GB76751327417 |
| BRAND NAME | SAMSUNG ELECTRONIC CO., LTD |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | THE GR40CW DIGITAL X-RAY IMAGING SYSTEM CONSISTS OF DETECTOR, POWER SUPPLY BOX, BATTERY PACK, BATTERY CHARGER, ACCESS POINT, CIB(CONTROL INTERFACE BOX), WORKSTATION, BARCODE SCANNER AND MAIN CABLE. THIS SYSTEM IS USED TO CAPTURE IMAGES BY TRANSMITTING X-RAY TO A PATIENT’S BODY. THE X-RAY PASSING THROUGH A PATIENT’S BODY IS SENT TO THE DETECTOR AND THEN CONVERTED INTO ELECTRICAL SIGNALS. THESE SIGNALS GO THROUGH THE PROCESS OF AMPLIFICATION AND DIGITAL DATA CONVERSION IN THE SIGNAL PROCESS DEVICE BEFORE BEING SENT TO THE S-STATION (OPERATION SOFTWARE) AND SAVED IN DICOM FILE, A STANDARD FOR MEDICAL IMAGING. THE CAPTURED IMAGES ARE SENT TO THE PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS) SERVER, AND CAN BE USED FOR READING IMAGES. |
| DEVICE INTENDED PURPOSE | IT IS INTENDED FOR USE IN GENERAL PROJECTION RADIOGRAPHIC APPLICATIONS WHEREVER CONVENTIONAL SCREEN-FILM SYSTEMS OR CR SYSTEMS MAY BE USED. |
| VALIDITY DATE OF REGISTRATION | 25/08/2022 - 24/08/2027 |