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DEVICE DETAILS

NAME OF DEVICEDIAGNOSTIC X-RAY SYSTEM GC85A
ESTABLISHMENT NAMELAC MEDICAL SUPPLIES SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC66959327217
BRAND NAMESAMSUNG ELECTRONIC CO., LTD
MEDICAL DEVICE CATEGORYMD 1201 - Imaging devices utilising ionizing radiation
DEVICE GROUPING TYPESYSTEM
DEVICE DESCRIPTIONTHE GC85A DIGITAL X-RAY IMAGING SYSTEM IS TO BE USED TO TAKE AND STORE IMAGE FOR DIAGNOSIS OF PATIENTS. IT CONSISTS OF THE HIGH VOLTAGE GENERATOR (HVG), CEILING SUSPENSION, DETECTOR, X-RAY TUBE, PATIENT TABLE, WALL STAND, COLLIMATOR AND ETC.
DEVICE INTENDED PURPOSETHE GC85A 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 REGISTRATION25/08/2022 - 24/08/2027

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