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DEVICE DETAILS

NAME OF DEVICEGM85 (C-TYPE, F-TYPE, FIT-TYPE)
ESTABLISHMENT NAMELAC MEDICAL SUPPLIES SDN BHD
REGISTRATION NOGC5394423-134640
BRAND NAMESAMSUNG ELECTRONIC CO.LTD.
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

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Digital Diagnostic Mobile X-ray SystemGM85 (C-Type)
2Digital Diagnostic Mobile X-ray SystemGM85 (F-Type)
3Digital Diagnostic Mobile X-ray SystemGM85 (Fit-Type)
4Digital Flat Panel X-ray DetectorS4335-W
5Digital Flat Panel X-ray DetectorS4343-W
6Digital Flat Panel X-ray DetectorS3025-W
7Digital Flat Panel X-ray DetectorS4335-AW
8Digital Flat Panel X-ray DetectorS4343-AW
9Digital Flat Panel X-ray DetectorFXRD-2530VAW PLUS (Brand name: S3025-AW)
10Digital Flat Panel X-ray DetectorFXRD-2530VAW (Brand name: S3025-AWM)
11Digital Flat Panel X-ray DetectorS4335-AWM
12Digital Flat Panel X-ray DetectorS4343-AWM
13Digital Flat Panel X-ray DetectorF4335-AW
14DAPDGR-ACCSHD
15High Voltage GeneratorSMG-40
16High Voltage GeneratorVenus-40-M
17X-ray TubeLUC-13L
18X-ray TubeLUC-11L
19X-ray TubeXRR-3332X
20CollimatorSDR-OGCL40U
21CollimatorSDR-OGCL41U
22CollimatorSDR-OGCL30L
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