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DEVICE DETAILS

NAME OF DEVICEDIAGNOSTIC X-RAY SYSTEM GC85A
ESTABLISHMENT NAMELAC MEDICAL SUPPLIES SDN BHD
REGISTRATION NOGC66959327217
BRAND NAMESAMSUNG ELECTRONIC CO., LTD
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
11System CabinetSDR-OGCA80U
12System CabinetSDR-OGCA75A
13System CabinetSDR-OGCA75B
14System CabinetSDR-OGCA75C
15System CabinetSDR-OGCA81A
16System CabinetSDR-OGCA81B
17Remote ControllerSDR-OGRC80U
18Remote ControllerSDR-OGRC81J
19Remote ControllerSDR-OGRC71A
20CIBSDR-OGCI80U
21Digital Flat Panel X-ray DetectorS4335-W
22Digital Flat Panel X-ray DetectorS4343-W
23Digital Flat Panel X-ray DetectorS3025-W
24Digital Flat Panel X-ray DetectorS4335-AW
25Digital Flat Panel X-ray DetectorS4343-AW
26Digital Flat Panel X-ray DetectorFXRD-2530VAW PLUS (Brand name: S3025-AW)
27Digital Flat Panel X-ray DetectorFXRD-2530VAW (Brand name: S3025-AWM)
28Digital Flat Panel X-ray DetectorS4335-AWM
29Digital Flat Panel X-ray DetectorS4343-AWM
30Digital Flat Panel X-ray DetectorF4335-AW
31Wall StandSDR-OGST80U
32Wall StandSDR-OGST73A
33Wall StandSDR-OGST73B
34Wall StandSDR-OGST73C
35Ceiling SuspensionSDR-OGTS80U
36Patient TableSDR-OGTA80U
37Foot Switch(Stand)SDR-OGSF10A
38Foot Switch(Stand)SDR-OGSF80L
39Foot Switch(Table)SDR-OGSF70A
40Foot Switch(Table)SDR-OGSF81L
41Auto Stitching StandSDR-OGAS70A
42Grid HolderSDR-OGGH70A
43Compressing BeltSDR-OGCB70A
44Detector HolderSDR-OGDH70A