Accelerator, Linear, Medical

Who Makes This Device Type in China?

8 manufacturers in China hold an FDA registration for this device type, concentrated in Beijing, Guangdong and Jiangsu, and 2 other provinces. 3 of them are contract manufacturers, able to build to a buyer’s own specification.

Elekta Beijing Medical Systems Co., Ltd. Beijing, contract manufacturer
Guangzhou Tian Hong Medical Technology Co., Ltd. Guangdong, contract manufacturer
Jiangsu Rayer Medical Technology Co., Ltd. Jiangsu
Klarity Medical & Equipment (GZ) Co., Ltd. Guangdong, contract manufacturer
Manteia Technologies Co., Ltd. Fujian
OUR United Corporation Shaanxi, contract manufacturer
Suzhou Linatech Medical Science AND Technology Co., Ltd. Jiangsu
Varian Medical Systems China Co., Ltd. Beijing

How Is IYE Classified?

Accelerator, Linear, Medical is FDA product code IYE, Class 2, 21 CFR 892.5050.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 11 clearances under this code; the FDA took a median of 235 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 563 recalls under this product code since 0013. None was by a company in China. The root causes the FDA records most often are Software design (233), Device Design (92) and Nonconforming Material/Component (32).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Accelerator, Linear, Medical

Standard Imaging IMSure 3d

Standard Imaging IMSure 3D (IM3D) QA software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy.

Accelerator, Linear, Medical

emXX4Tera Für Zebra

Catalogue number E3055000#001, listed by IBA Dosimetry GmbH, Germany, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

System WingSTEP High – Pin Joint

Catalogue number P10107-741, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Sbrt Secure Arch, Size M

Catalogue number SSA-M, listed by Macromedics B.V., under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Visual Coaching Device (VCD)

Catalogue number 3.0, listed by Varian Medical Systems, Inc, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Sentinel

Catalogue number SP001, listed by C-RAD Positioning AB, Sweden, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

System HeadSTEP Bite Wide

Catalogue number P10107-791, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Knee Support

Catalogue number 60-540, listed by Aktina Medical Corp., United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Standard Panel for Aktina Igrt Table Top

Catalogue number 11-215, listed by Aktina Medical Corp., United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Fixator™ Shoulder Cups

Catalogue number MTCFHN006SUB6, listed by Medtec LLC, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Wedge Filter, Cross- Plane, Digital, 30 Degrees, Siemens

Catalogue number 56-300-DX30, listed by Aktina Medical Corp., United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

System WingSTEP Low – Ball Joint

Catalogue number P10107-742, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Raypilot Power Box

Raypilot Power Box is connected between electrical supply and Raypilot Receiver by Raypilot Transmitter Cable. It is also connected to the dedicated computer by an ethernet cable.

Accelerator, Linear, Medical

Aria Oncology Information System – Radiation Oncology

Catalogue number 13.7, listed by Varian Medical Systems, Inc, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Indexing Bar

Catalogue number 60-545, listed by Aktina Medical Corp., United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Ethos Treatment Planning

Ethos Treatment Planning version 2.0 generates and modifies radiation therapy treatment plans for qualified medical professionals. It supports conventional treatment planning and adaptive…

Accelerator, Linear, Medical

Target Positioner

Catalogue number 40700-10A, listed by Brainlab SE, Germany, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

S-Type Baseplate, MR

S-Type baseplate, MR safe, 2P

Accelerator, Linear, Medical

iCAST H&N Maxi Head Double 4mm

Catalogue number P10107-308, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Beam Block Tray, Lexan, Slotted, Set of 10

Catalogue number 11-575, listed by Aktina Medical Corp., United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

OmniBoard™ BTM

OmniBoard Breast Treatment Module

Accelerator, Linear, Medical

HS Bite Angulating Fixation Set Narrow

Catalogue number P10107-448, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Circular Small Field Cone Insert, Elekta, 17mm

Catalogue number 50-302-170, listed by Aktina Medical Corp., United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Electron Energy Verification Wedge

Accessory to the Model 1174 PROFILER 2.

Accelerator, Linear, Medical

Wedge Filter, Cross- Plane, Digital, 15 Degrees, Siemens

Catalogue number 56-300-DX15, listed by Aktina Medical Corp., United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

System TBI Step 2,1m for Varian

Catalogue number P10107-758, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

MoldCARE Cushion Trapezoid

Catalogue number P10107-646, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Leps™ Baseplate Short

Lower Extremity Positioning System, baseplate, short, 3P

Accelerator, Linear, Medical

KneeSupport™ Low,plastic

KneeSupport low, plastic, 3P

Accelerator, Linear, Medical

Circular Small Field Cone Insert, Elekta, 35mm

Catalogue number 50-302-350, listed by Aktina Medical Corp., United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

MCT Wedge Evo Indexed

Catalogue number P10107-478, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

FeetSTEP Pro Carbon Incl. Sliding Bed

Catalogue number P10107-192, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

HeadSTEP Imrt MR Basic Module

Catalogue number P10107-401, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

VacuumCushion 120×120 T

Vacuum Cushion, body support, T-shape 120x120cm

Accelerator, Linear, Medical

Indexing Bar 100mm Offcentered for Varian

Catalogue number P10107-630, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

BellySTEP Insert C – Small

Catalogue number P10107-163, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Thermo Bolus 10x10x0,5cm – Non Perforated (5pcs)

Catalogue number P10107-649, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

TrueBeam Radiotherapy System

TrueBeam is a medical linear accelerator used to deliver precision radiotherapy and stereotactic radiosurgery. It treats lesions, tumors and other conditions for which radiation therapy is…

Accelerator, Linear, Medical

Circular Small Field Cone Insert, Elekta, 19mm

Catalogue number 50-302-190, listed by Aktina Medical Corp., United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Dsps® Cradle-MEXF H

DSPS® Cradle Type MacroMedics® ExaFix, high

Accelerator, Linear, Medical

Pillow No Sidewall K

Catalogue number P10107-231, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Cranial AS for Bblx/TS, Set/2

Cranial adjustable arm supports with high armcup, set of 2

Accelerator, Linear, Medical

CouchStrip Csmfcf

CouchStrip, medium, fixed, carbon fiber, 2P

Accelerator, Linear, Medical

System HeadSTEP Shoulder

Catalogue number P10107-706, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Localization Bridge

Catalogue number 60-280, listed by Aktina Medical Corp., United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

WingSTEP Pole Bridge Bar (Add on System)

Catalogue number P10107-522, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Pillow Standard a – Low Density

Catalogue number P10107-211, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

ONEPlatform™ – Short

Catalogue number BPL004, listed by Medtec LLC, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

System BreastSTEP Indexed Short MR

Catalogue number P10107-722, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

OmniBoard™ 3.0 base,RE

OmniBoard 3.0 RealEase

Accelerator, Linear, Medical

CyberKnife® VSI™ Robotic Radiosurgery System

Catalogue number 033000-000, listed by Accuray Incorporated, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

System BreastSTEP Prone US

Catalogue number P10107-725, listed by It-V Medizintechnik, GmbH, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

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