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DEVICE DETAILS

NAME OF DEVICEGM85 (C-TYPE, F-TYPE, FIT-TYPE)
ESTABLISHMENT NAMELAC MEDICAL SUPPLIES SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC5394423-134640
BRAND NAMESAMSUNG ELECTRONIC CO.LTD.
MEDICAL DEVICE CATEGORYMD 1201 - Imaging devices utilising ionizing radiation
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe GM85 digital X-ray imaging system consists of the built-in high voltage generator, X-ray tube, control panel, mobile system for movement, detector and the S-station (operation software).
DEVICE INTENDED PURPOSEThe GM85 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/ trained doctor or technician. This device is not intended for mammographic applications.
VALIDITY DATE OF REGISTRATION08/06/2023 - 07/06/2028

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