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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

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Diagnostic X-ray SystemGC85A
2X-ray tube E7869X
3X-ray tube E7252X
4Diagnostic X-ray High Voltage GeneratorGXR-82
5Diagnostic X-ray High Voltage GeneratorGXR-52
6Diagnostic X-ray High Voltage GeneratorZR75PN80
7Diagnostic X-ray High Voltage GeneratorZR75PN50
8CollimatorSDR-OGCL80U
9CollimatorSDR-OGCL83U
10CollimatorSDR-OGCL81U
11CollimatorSDR-OGCL83N
12System CabinetSDR-OGCA80U
13System CabinetSDR-OGCA75A
14System CabinetSDR-OGCA75B
15System CabinetSDR-OGCA75C
16System CabinetSDR-OGCA81A
17System CabinetSDR-OGCA81B
18Remote ControllerSDR-OGRC80U
19Remote ControllerSDR-OGRC81J
20Remote ControllerSDR-OGRC71A
21CIBSDR-OGCI80U
22Digital Flat Panel X-ray DetectorS4335-W
23Digital Flat Panel X-ray DetectorS4343-W
24Digital Flat Panel X-ray DetectorS3025-W
25Digital Flat Panel X-ray DetectorS4335-AW
26Digital Flat Panel X-ray DetectorS4343-AW
27Digital Flat Panel X-ray DetectorFXRD-2530VAW PLUS (Brand name: S3025-AW)
28Digital Flat Panel X-ray DetectorFXRD-2530VAW (Brand name: S3025-AWM)
29Digital Flat Panel X-ray DetectorS4335-AWM
30Digital Flat Panel X-ray DetectorS4343-AWM
31Digital Flat Panel X-ray DetectorF4335-AW
32Digital Flat Panel X-ray DetectorF4343-AW
33Wall StandSDR-OGST80U
34Wall StandSDR-OGST73A
35Wall StandSDR-OGST73B
36Wall StandSDR-OGST73C
37Ceiling SuspensionSDR-OGTS80U
38Ceiling SuspensionSDR-OGTS80N
39Patient TableSDR-OGTA80U
40Foot Switch(Stand)SDR-OGSF10A
41Foot Switch(Stand)SDR-OGSF80L
42Foot Switch(Table)SDR-OGSF70A
43Foot Switch(Table)SDR-OGSF81L
44Auto Stitching StandSDR-OGAS70A
45Grid HolderSDR-OGGH70A
46Compressing BeltSDR-OGCB70A
47Detector HolderSDR-OGDH70A
48Lateral Support BarSDR-OGBA80N
49Lateral Support BarSDR-OGBA81N
50Wired X-ray Exposure switchF29-9A
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