Radiology › TherapeuticAccelerator, Linear, Medical

Fibreplast®

Fibreplast Open View, Open Neck Hd+Shldr S-Frame, 3.2mm, Variable Perf with Integrated Shim

Registry build 21.09.26
8manufacturers in China registered for this device type
271catalogue numbers in this listing
6510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (2), Beijing (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IYE
Manufacturer City Province Registered as Device types
Guangzhou Tian Hong Medical Technology Co., Ltd. Guangzhou Guangdong Contract manufacturer 4
Klarity Medical & Equipment (GZ) Co., Ltd. Guangzhou Guangdong Contract manufacturer 3
Elekta Beijing Medical Systems Co., Ltd. Beijing Beijing Contract manufacturer 1
Manteia Technologies Co., Ltd. Xiamen Fujian Manufacturer 3
OUR United Corporation Xian Shaanxi Contract manufacturer 2
Suzhou Linatech Medical Science AND Technology Co., Ltd. Suzhou Jiangsu Manufacturer 2
Varian Medical Systems China Co., Ltd. Beijing Beijing Manufacturer 2
Jiangsu Rayer Medical Technology Co., Ltd. Wuxi Jiangsu Manufacturer 1

Record

Regulatory record for Fibreplast®
Listed by Qfix, United States
FDA product code IYE
Device type Accelerator, Linear, Medical
Device class Class 2
Regulation 21 CFR 892.5050
510(k) K935067
Record published 2021-12-17
Record revised 2026-02-16 (version 6)

Specifications

Specifications
MRI safety MR Safe
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Sizes Depth 2.4 to 3.2 mm; width 26 to 48 cm; width 24 to 36 in; length 18 to 24 in
Distribution end date 2026-03-10

Catalogue Numbers

Catalogue numbers for Fibreplast®
Catalogue number Size Per pack Status
RT-1779KSL Depth 2.4 mm 5 In distribution
RT-1782KORF5 Depth 2.4 mm 10 In distribution
RT-1882KBOS-DVS Depth 3.2 mm 10 In distribution
RT-1882KP Depth 3.2 mm 5 In distribution
RT-1782KSD Depth 2.4 mm 10 In distribution
RT-1882KBOS-DS Depth 3.2 mm 10 In distribution
RT-1892KESD Depth 3.2 mm 10 In distribution
RT-1779KESD Depth 2.4 mm 10 In distribution
RT-1889KSD-S3 Depth 3.2 mm 10 In distribution
RT-1889KESDL Depth 3.2 mm 10 In distribution
RT-1778KORF5 Depth 2.4 mm 10 In distribution
RT-1776KSDGXF Depth 2.4 mm 10 In distribution
RT-1779KSD Depth 2.4 mm 10 In distribution
RT-1889KSX Depth 3.2 mm 5 In distribution
RT-1892KBOS-A2L Depth 3.2 mm 5 In distribution
RT-1778KORF3 Depth 2.4 mm 10 In distribution
RT-1889KSD Depth 3.2 mm 10 In distribution
RT-1779KSX Depth 2.4 mm 5 In distribution
RT-1882KBOS-D Depth 3.2 mm 10 In distribution
RT-1892KBOS-C Depth 3.2 mm 5 In distribution
RT-1882KBOS-DXS Depth 3.2 mm 10 In distribution
RT-1878KBOS-D2LS Width 31 cm 10 In distribution
RT-1778KPR3D Depth 2.4 mm 10 In distribution
RT-1889KS Depth 3.2 mm 5 In distribution
RT-1782KORF3 Depth 2.4 mm 10 In distribution
RT-1779KS Depth 2.4 mm 5 In distribution
RT-1782KESD Depth 2.4 mm 10 In distribution
RT-1878KBOS-D2LVS Width 26 cm 10 In distribution
RT-1778KPR5D Depth 2.4 mm 10 In distribution
RT-1889KSL Depth 3.2 mm 5 In distribution
RT-1819KSX Depth 3.2 mm 5 In distribution
RT-1878KBOS-E2L Depth 3.2 mm 10 In distribution
RT-1889KSO Depth 3.2 mm 5 In distribution
RT-1889KSDL Depth 3.2 mm 10 In distribution
RT-1821KP Depth 3.2 mm 10 In distribution
RT-1882KBOS-ES Width 43 cm 10 In distribution
RT-1782KPR3D Depth 2.4 mm 10 In distribution
RT-1882KBOS-E Depth 3.2 mm 10 In distribution
RT-1882K Depth 3.2 mm 5 In distribution
RT-1782KPR5D Depth 2.4 mm 10 In distribution
RT-1889KESD Depth 3.2 mm 10 In distribution
RT-1892KSD Depth 3.2 mm 10 In distribution
RT-1878KBOS-E2LS Width 43 cm 10 In distribution
RT-A182KYSDN In distribution
RT-1878KBOS-D2L Depth 3.2 mm 10 In distribution
RT-1889KS-S3 Depth 3.2 mm 5 In distribution
RT-1896K Depth 3.2 mm Withdrawn
RT-1889KSDX Depth 3.2 mm Withdrawn
RT-1882KBOS-DS Depth 3.2 mm 10 Withdrawn
RT-1779KSX Depth 2.4 mm Withdrawn
RT-1892KBOS-A2L Depth 3.2 mm Withdrawn
RT-1778KPR3D Depth 2.4 mm Withdrawn
RT-1782KESD Depth 2.4 mm Withdrawn
RT-1782KORF3 Depth 2.4 mm Withdrawn
RT-1892K Depth 3.2 mm Withdrawn
RT-1889KSO Depth 3.2 mm Withdrawn
RT-1778KPR3 Depth 2.4 mm Withdrawn
RT-1876KSDGL Depth 3.2 mm Withdrawn
RT-1892K Depth 3.2 mm Withdrawn
RT-1782KPR3 Depth 2.4 mm 10 Withdrawn
RT-1878KBOS-D2LVS Width 26 cm Withdrawn
RT-1889KESD Depth 3.2 mm 10 Withdrawn
RT-1889KSO Depth 3.2 mm Withdrawn
RT-1784K Length 24 in Withdrawn
RT-1779KSD Depth 2.4 mm Withdrawn
RT-1784K Length 24 in 5 Withdrawn
RT-1778KPR3D Depth 2.4 mm Withdrawn
RT-1889KSD Depth 3.2 mm Withdrawn
RT-1878KBOS-E2LS Width 43 cm Withdrawn
RT-1892KSD Depth 3.2 mm 10 Withdrawn
RT-1779KSL Depth 2.4 mm Withdrawn
RT-1778KORF5 Depth 2.4 mm 5 Withdrawn
RT-1778KORF5 Depth 2.4 mm Withdrawn
RT-1779KSD Depth 2.4 mm 10 Withdrawn
RT-1889KSDX Depth 3.2 mm 10 Withdrawn
RT-1882KBOS-DXS Depth 3.2 mm Withdrawn
RT-1779KR Depth 2.4 mm 5 Withdrawn
RT-1779KESDX Depth 2.4 mm Withdrawn
RT-1782KSD Depth 2.4 mm 10 Withdrawn
RT-1778KORF3 Depth 2.4 mm 10 Withdrawn
RT-1779KS Depth 2.4 mm Withdrawn
RT-1889KSX Depth 3.2 mm Withdrawn
RT-1776KSXF Depth 2.4 mm Withdrawn
RT-1892KESD Depth 3.2 mm 10 Withdrawn
RT-1779KS Depth 2.4 mm Withdrawn
RT-1889KSO Depth 3.2 mm 5 Withdrawn
RT-1882KBOS-DVS Depth 3.2 mm 10 Withdrawn
RT-1889KESDL Depth 3.2 mm Withdrawn
RT-1878KBOS-D2L Depth 3.2 mm Withdrawn
RT-1782KS Depth 2.4 mm 10 Withdrawn
RT-1889KSD-S3 Depth 3.2 mm Withdrawn
RT-1819KSX Depth 3.2 mm Withdrawn
RT-1896K Length 24 in 5 Withdrawn
RT-1782KORF5 Depth 2.4 mm 5 Withdrawn
RT-1889KS-S3 Depth 3.2 mm Withdrawn
RT-1889KS Depth 3.2 mm 5 Withdrawn
RT-1782KORF3 Depth 2.4 mm 10 Withdrawn
RT-1882KBOS-E Depth 3.2 mm Withdrawn
RT-1778KORF3 Depth 2.4 mm Withdrawn
RT-1876KSDGL Depth 3.2 mm 10 Withdrawn
RT-1779KESD Depth 2.4 mm Withdrawn
RT-1889KS-S3 Depth 3.2 mm Withdrawn
RT-1778KORF3 Depth 2.4 mm 5 Withdrawn
RT-1782KORF3 Depth 2.4 mm Withdrawn
RT-1896K Depth 3.2 mm 5 Withdrawn
RT-1782KORF5 Depth 2.4 mm 10 Withdrawn
RT-1778KPR5D Depth 2.4 mm Withdrawn
RT-1784K Depth 2.4 mm 5 Withdrawn
RT-1889KESDX Depth 3.2 mm 10 Withdrawn
RT-1882KBOS-E Depth 3.2 mm Withdrawn
RT-1821KP Depth 3.2 mm 10 Withdrawn
RT-1779KESD Depth 2.4 mm 10 Withdrawn
RT-1892KBOS-C Depth 3.2 mm Withdrawn
RT-1782KPR3D Depth 2.4 mm 5 Withdrawn
RT-1882KBOS-DXS Depth 3.2 mm 10 Withdrawn
RT-1779KSDL Depth 2.4 mm Withdrawn
RT-1889KSDL Depth 3.2 mm Withdrawn
RT-1778KORF3 Depth 2.4 mm Withdrawn
RT-1778KPR5 Depth 2.4 mm Withdrawn
RT-1779KESDX Depth 2.4 mm Withdrawn
RT-1882KBOS-D Depth 3.2 mm Withdrawn
RT-1889KESDL Depth 3.2 mm Withdrawn
RT-1878KBOS-E2LS Width 43 cm Withdrawn
RT-1782KPR3 Depth 2.4 mm Withdrawn
RT-1878KBOS-E2L Depth 3.2 mm Withdrawn
RT-1882KBOS-E Depth 3.2 mm 10 Withdrawn
RT-1889KSDL Depth 3.2 mm Withdrawn
RT-1889KSD Depth 3.2 mm Withdrawn
RT-1819KS Depth 3.2 mm 5 Withdrawn
RT-1892KESD Depth 3.2 mm Withdrawn
RT-1776KSDGXF Depth 2.4 mm Withdrawn
RT-1882K Length 18 in Withdrawn
RT-1889KSXO Depth 3.2 mm Withdrawn
RT-1819KS Depth 3.2 mm 5 Withdrawn
RT-1878K Width 24 in 5 Withdrawn
RT-1878KBOS-D2LS Width 31 cm Withdrawn
RT-1782KESD Depth 2.4 mm Withdrawn
RT-1779KSDX Depth 2.4 mm 10 Withdrawn
RT-1882KP Depth 3.2 mm Withdrawn
RT-1779KR Depth 2.4 mm Withdrawn
RT-1779KESDL Depth 2.4 mm 10 Withdrawn
RT-1782KORF5 Depth 2.4 mm Withdrawn
RT-1892KESD Depth 3.2 mm Withdrawn
RT-1778KPR5D Depth 2.4 mm Withdrawn
RT-1782KPR5 Depth 2.4 mm 10 Withdrawn
RT-1892KSD Depth 3.2 mm Withdrawn
RT-1892KBOS-C Depth 3.2 mm 5 Withdrawn
RT-1892KBOS-A2L Depth 3.2 mm Withdrawn
RT-1878KBOS-E2LS Width 43 cm 10 Withdrawn
RT-1882KBOS-D Depth 3.2 mm 10 Withdrawn
RT-1778KPR3D Depth 2.4 mm 5 Withdrawn
RT-1889KSD-S3 Depth 3.2 mm Withdrawn
RT-1878K Width 24 in Withdrawn
RT-1889KSX Depth 3.2 mm 5 Withdrawn
RT-1782KPR5D Depth 2.4 mm 10 Withdrawn
RT-1889KESDX Depth 3.2 mm Withdrawn
RT-1878KBOS-D2LVS Width 26 cm 10 Withdrawn
RT-1782KORF5 Depth 2.4 mm Withdrawn
RT-1778KPR5 Depth 2.4 mm 10 Withdrawn
RT-1779KSDX Depth 2.4 mm 10 Withdrawn
RT-1779KSD-S3 Depth 2.4 mm 10 Withdrawn
RT-1876KSDGL Depth 3.2 mm 10 Withdrawn
RT-1778KORF5 Depth 2.4 mm 10 Withdrawn
RT-1876KSDGL Depth 3.2 mm Withdrawn
RT-1776KSXF Depth 2.4 mm Withdrawn
RT-1878KBOS-D2LVS Width 26 cm Withdrawn
RT-1896K Depth 3.2 mm Withdrawn
RT-1889KSXO Depth 3.2 mm Withdrawn
RT-1878KBOS-D2LS Depth 3.2 mm 10 Withdrawn
RT-1782KPR3D Depth 2.4 mm Withdrawn
RT-1779KSDX Depth 2.4 mm Withdrawn
RT-1822K Length 18 in Withdrawn
RT-1779KS-S3 Depth 2.4 mm 5 Withdrawn
RT-1779KS Depth 2.4 mm 5 Withdrawn
RT-1779KSDX Depth 2.4 mm Withdrawn
RT-1776KSDGXF Depth 2.4 mm Withdrawn
RT-1878KBOS-D2LS Width 31 cm Withdrawn
RT-1878K Length 18 in 5 Withdrawn
RT-1819KSX Depth 3.2 mm Withdrawn
RT-1782KESD Depth 2.4 mm 10 Withdrawn
RT-1778KPR5D Depth 2.4 mm 5 Withdrawn
RT-1782KS Depth 2.4 mm 10 Withdrawn
RT-1822K Depth 3.2 mm 5 Withdrawn
RT-1779KSDL Depth 2.4 mm Withdrawn
RT-1819KSX Depth 3.2 mm 5 Withdrawn
RT-1819KS Depth 3.2 mm Withdrawn
RT-1778KPR3 Depth 2.4 mm 10 Withdrawn
RT-1889KESDL Depth 3.2 mm 10 Withdrawn
RT-1889KS Depth 3.2 mm Withdrawn
RT-1778KPR3D Depth 2.4 mm 10 Withdrawn
RT-1889KSDL Depth 3.2 mm 10 Withdrawn
RT-1892KBOS-C Depth 3.2 mm Withdrawn
RT-1776KSXF Depth 2.4 mm 5 Withdrawn
RT-1782KORF3 Depth 2.4 mm 5 Withdrawn
RT-1782KSD Depth 2.4 mm Withdrawn
RT-1779KSDL Depth 2.4 mm 10 Withdrawn
RT-1889KSXO Depth 3.2 mm 5 Withdrawn
RT-1779KESDL Depth 2.4 mm Withdrawn
RT-1878KBOS-D2L Depth 3.2 mm 10 Withdrawn
RT-1819KS Depth 3.2 mm Withdrawn
RT-1779KESDX Depth 2.4 mm 10 Withdrawn
RT-1782KPR3D Depth 2.4 mm Withdrawn
RT-1779KSX Depth 2.4 mm Withdrawn
RT-1779KSD Depth 2.4 mm Withdrawn
RT-1882KP Depth 3.2 mm Withdrawn
RT-1892KBOS-A2L Depth 3.2 mm 5 Withdrawn
RT-1878K Width 24 in Withdrawn
RT-1779KSL Depth 2.4 mm 5 Withdrawn
RT-1782KPR3D Depth 2.4 mm 10 Withdrawn
RT-1892K Width 24 in 5 Withdrawn
RT-1779KESDL Depth 2.4 mm Withdrawn
RT-1889KSDX Depth 3.2 mm 10 Withdrawn
RT-1878KBOS-E2L Depth 3.2 mm Withdrawn
RT-1892KSD Depth 3.2 mm Withdrawn
RT-1779KESDX Depth 2.4 mm 10 Withdrawn
RT-1779KSD-S3 Depth 2.4 mm Withdrawn
RT-1889KESDX Depth 3.2 mm 10 Withdrawn
RT-1889KSDX Depth 3.2 mm Withdrawn
RT-1878KBOS-D2L Depth 3.2 mm Withdrawn
RT-1883KP12A Depth 3.2 mm Withdrawn
RT-1889KSX Depth 3.2 mm Withdrawn
RT-1882KBOS-ES Width 43 cm Withdrawn
RT-1883KP12A Depth 3.2 mm 5 Withdrawn
RT-1889KS-S3 Depth 3.2 mm 5 Withdrawn
RT-1779KSL Depth 2.4 mm Withdrawn
RT-1882KBOS-DVS Depth 3.2 mm Withdrawn
RT-1779KR Depth 2.4 mm Withdrawn
RT-1882KBOS-DS Depth 3.2 mm Withdrawn
RT-1889KESD Depth 3.2 mm Withdrawn
RT-1779KESDL Depth 2.4 mm 10 Withdrawn
RT-1779KR Depth 2.4 mm 5 Withdrawn
RT-1782KPR5 Depth 2.4 mm Withdrawn
RT-1782KPR5D Depth 2.4 mm Withdrawn
RT-1782KPR5D Depth 2.4 mm Withdrawn
RT-1782KSD Depth 2.4 mm Withdrawn
RT-1782KPR4 Depth 2.4 mm Withdrawn
RT-1889KS Depth 3.2 mm Withdrawn
RT-1882KBOS-DVS Depth 3.2 mm Withdrawn
RT-1776KSDGXF Depth 2.4 mm 10 Withdrawn
RT-1889KSD-S3 Depth 3.2 mm 10 Withdrawn
RT-1889KSXO Depth 3.2 mm 5 Withdrawn
RT-1784K Length 24 in Withdrawn
RT-1882KBOS-ES Width 43 cm 10 Withdrawn
RT-1778KORF5 Depth 2.4 mm Withdrawn
RT-1889KSD Depth 3.2 mm 10 Withdrawn
RT-1882KBOS-DS Depth 3.2 mm Withdrawn
RT-1779KESD Depth 2.4 mm Withdrawn
RT-1782KPR4 Depth 2.4 mm 10 Withdrawn
RT-1782KS Depth 2.4 mm Withdrawn
RT-1878KBOS-E2L Depth 3.2 mm 10 Withdrawn

Showing 250 of 271 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Klarity Medical Klarity Medical Products, LLC 891
Orfit Industries Orfit Industries NV 680
Aquaplast RT™ Qfix 569
Bionix Radiation Therapy Bionix Radiation Therapy, LLC 115
Vac-Lok™ Cushion Medtec LLC 100
Visicoil IZI Medical Products LLC 86
BodyFIX 3C-Medical Intelligence GmbH 84
AlignRT Plus Vision RT Limited 72
Fibreplast® Assure™ Open View Qfix 72
Accelerator, Linear, Medical PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 71
Thermoplastic Mask IZI Medical Products LLC 58
Gold Anchor Naslund Medical AB 58

Showing 12 of 1,611. All products under Accelerator, Linear, Medical

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K230312 2023-03-31
K193243 2020-02-28
K182189 2018-10-04
K171133 2017-07-11
K160627 2016-06-14
K152321 2015-12-04

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer