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DEVICE DETAILS

NAME OF DEVICEIC Profiler
ESTABLISHMENT NAMEONCORAY SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGA9896721-57342
BRAND NAMESun Nuclear
MEDICAL DEVICE CATEGORYELECTRO MECHANICAL MEDICAL DEVICES
DEVICE GROUPING TYPESYSTEM
DEVICE DESCRIPTIONThe models 1122 and 1122-MR IC PROFILER are intended for quality assurance measurements of a radiation therapy beam from a radiotherapy treatment delivery device (TDD). The model 1122-MR is intended to operate in the magnetic field created by a TDD. Collected data is not intended for commissioning treatment planning systems or calibrating beam output
DEVICE INTENDED PURPOSEThe models 1122 and 1122-MR IC PROFILER are intended for quality assurance measurements of a radiation therapy beam from a radiotherapy treatment delivery device (TDD). The model 1122-MR is intended to operate in the magnetic field created by a TDD. Collected data is not intended for commissioning treatment planning systems or calibrating beam output
VALIDITY DATE OF REGISTRATION22/03/2021 - 21/03/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1IC Profiler, Solid Water, Quad Wedge, and Accessories Storage Case1122690
2Gantry Mounting Fixture, Elekta Agility1122000-EAZ
3Gantry Mounting Fixture, Varian1122000-VZ
4Electron Energy Double Wedge Plate1122602Z
5Photon Energy Quad Wedge Plate1122655Z
6Electron Energy Quad Wedge Plate1122656Z
7Energy Verification Tools Set1122664Z
8Adapter plate for the GMF (1122000-V and 1122000-E)1122-AZ
9Solid Water HE 0.2cm1174111Z
10Solid Water HE 0.3cm1174112Z
11Solid Water HE 0.5cm1174113Z
12Solid Water HE 1.0cm1174114Z
13Solid Water HE 2.0cm1174115Z
14Solid Water HE 5.0cm1174116Z
15Solid Water HE 3.0cm1174117Z
16Solid Water HE 4.0cm1174118Z
17IC PROFILER-MR1122000-0MRZ
18IC PROFILER Beam Scanning 1122000-0Z
19Halcyon Acceptance Test Tools1122000-PH
20ICP SOLID WATER HE 35.3 x 36.7 x 2.0cm CHAMBER - A805683
21ICP SOLID WATER HE 35.3 x 36.7 x 2.0cm CHAMBER - B805684
22PF2 AND MC3 SOLID WATER HE 30.0 X 35.2 X 2.0 CHAMBER - A805691
23PF2 AND MC3 SOLID WATER HE 30.0 X 35.2 X 2.0 CHAMBER - B805692
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