This facility is provided to enable any interested parties to search for Registered Medical Device, Registered CAB, Licensed Establishments under Section 5, 10, 15 of Medical Device Act 2012 (Act 737) respectively and Notified Medical Device under Medical Device (Exemption) Order 2016. Any party who wishes to know whether an establishment who is dealing with medical device has been licensed under Act 737 may search the establishment by inserting the establishment name or license number in the searching field below.


  1. Home
  2. Registered Medical Device Search
  1. Print

DEVICE DETAILS

NAME OF DEVICEGR40CW
ESTABLISHMENT NAMELAC MEDICAL SUPPLIES SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB76751327417
BRAND NAMESAMSUNG ELECTRONIC CO., LTD
MEDICAL DEVICE CATEGORYMD 1202 - Imaging devices utilising non-ionizing radiation
DEVICE GROUPING TYPESYSTEM
DEVICE DESCRIPTIONTHE 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 PURPOSEIT IS INTENDED FOR USE IN GENERAL PROJECTION RADIOGRAPHIC APPLICATIONS WHEREVER CONVENTIONAL SCREEN-FILM SYSTEMS OR CR SYSTEMS MAY BE USED.
VALIDITY DATE OF REGISTRATION25/08/2022 - 24/08/2027

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
No results found.
Back