Radiology › Therapeutic

Which Manufacturers in China Work in This Section?

19 manufacturers in China hold an FDA registration for a device type in this section, concentrated in Guangdong, Jiangsu and Beijing, and 5 other provinces. 6 of them are contract manufacturers. Chinese manufacturers are registered for 6 of 45 device types here.

2 of those 6 device types need no premarket submission before sale in the United States. The FDA has recorded 1,058 recalls across the section’s product codes; the root causes it names most often are Software design (415), Device Design (158) and Nonconforming Material/Component (52).

Which Device Types Are Made in China?

The device types with the most Chinese manufacturers are Accelerator, Linear, Medical (8), Monitor, Patient Position, Light-Beam (5), System, Planning, Radiation Therapy Treatment (5), System, Radiation Therapy, Radionuclide (3) and X-Ray Field Indicator Light (Laser) (2). All 6 device types in this section with a Chinese manufacturer, most manufacturers first:

Accelerator, Linear, Medical 8 manufacturers
Monitor, Patient Position, Light-Beam 5 manufacturers
System, Planning, Radiation Therapy Treatment 5 manufacturers
System, Radiation Therapy, Radionuclide 3 manufacturers
X-Ray Field Indicator Light (Laser) 2 manufacturers
Prostate Immobilizer Rectal Balloon 1 manufacturer

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.

Monitor, Patient Position, Light-Beam

Cross-Hair Reticule, Radiation Opaque

Catalogue number 54-224, listed by Aktina Medical Corp., United States, under Monitor, Patient Position, Light-Beam. 5 manufacturers in China are registered for this product code.

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

System, Radiation Therapy, Radionuclide

GammaPod™

Stereotactic Radiotherapy System

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

System, Radiation Therapy, Radionuclide

Galaxy RTi

Galaxy RTi is a rotating gamma teletherapy system for stereotactic irradiation of structures in the adult head. It uses thirty cobalt-60 sources arranged within a shielded source carrier to…

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.

System, Planning, Radiation Therapy Treatment

Multimodality Simulation Workspace (MM Sim)1.0 Upgrade

Catalogue number Multimodality Simulation Workspace (MM S, listed by Philips Medical Systems Nederland B.V., Netherlands, under System, Planning, Radiation Therapy Treatment. 5 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.

System, Planning, Radiation Therapy Treatment

Delivery Analysis

Software, Delivery Analysis, Version 1.2.1

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.

Accelerator, Linear, Medical

Head Frame Cranial Screws, Short

Pouch of 2

Accelerator, Linear, Medical

System WingSTEP Carbon Low – Pin Joint

Catalogue number P10107-751, 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

iCAST H&S Maxi 2mm

Catalogue number P10107-304, 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 180×80

Vacuum Cushion, body support, 180x80cm, 68L Fill

Accelerator, Linear, Medical

SnapFrame™ Type-S™ Thermoplastic

Head, neck and shoulder FirmFit™ thermoplastic (2.3mm)

Accelerator, Linear, Medical

Kneefix™ 3

(41 x 41 x 16cm) high cushion

Accelerator, Linear, Medical

Fiducial Needles

Catalogue number FN17-3, listed by Riverpoint Medical LLC, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

PositionPro Pitch/Roll Baseboard

Catalogue number 50-840, listed by Aktina Medical Corp., United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Cranial 4PI Headrest Inlay Standard

Catalogue number 43446B, listed by Brainlab SE, Germany, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

FoamSTEP Pillow 240x250x10

Catalogue number P10107-463, 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

Stradivarius™

Compression Paddle for Stradivarius SBRT System

Accelerator, Linear, Medical

myQA Machines

Catalogue number MQ03-000, listed by IBA Dosimetry GmbH, Germany, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Multifix™ Baseplate

(carbon fiber)

Accelerator, Linear, Medical

Alatus

Alatus Vaginal Balloon Packing System Kit

Accelerator, Linear, Medical

iCAST Head Micro With Mouth Port 2,4mm

Catalogue number P10107-337, 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

System ProSTEP Short Carbon

Catalogue number P10107-796, 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

Pelvis Belly Replacement Stomach Cushion – Medium

Catalogue number PPRT-5104, listed by Bionix, LLC, United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

System HeelSTEP Light

Catalogue number P10107-731, 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

System BreastSTEP Indexed Long Mask

Catalogue number P10107-727, 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

Wall Holder for BreastSTEP

Catalogue number P10107-497, 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

Dorado

Catalogue number DORADOnova MR3T, listed by L A P Gmbh Laser Applikationen, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Mask Dsps®-OS

Mask DSPS-OS

Accelerator, Linear, Medical

FoamSTEP Semiroll 400 X 220 X 220 Dm (H110)

Catalogue number P10107-462, 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

Monarch™ Overhead Arm Positioner

Wingboard with attachment to C-Qual™ breastboard

System, Planning, Radiation Therapy Treatment

Ergo Localizer

Catalogue number ERGO Localizer, listed by Elekta Inc., United States, under System, Planning, Radiation Therapy Treatment. 5 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

VacuumCushion 60×80

Vacuum Cushion, body support,60x80cm, 11L Fill, Dark Blue

Accelerator, Linear, Medical

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

Catalogue number 56-300-DI15, listed by Aktina Medical Corp., United States, under Accelerator, Linear, Medical. 8 manufacturers in China are registered for this product code.

Accelerator, Linear, Medical

Raypilot Hypocath

Raypilot Hypocath is inteded for real time localization of a target during radiation therapy for men with prostate cancer. It is a Foley catheter with a transmitter inserted in one of the…

Accelerator, Linear, Medical

iFRAME Head Double

Catalogue number P10107-391, 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

DoseLab Pro

Dosimetry QA Software

Accelerator, Linear, Medical

BreastSTEP Prone Position Pillow

Catalogue number P10107-510, 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

System ProSTEP Elbow

Catalogue number P10107-786, 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

Agility™

Agility

Accelerator, Linear, Medical

MapRT Acquisition Software

MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential…

Accelerator, Linear, Medical

myQA SRS Detector Cyberknife Edition

myQA SRS Cyberknife edition

Accelerator, Linear, Medical

Indexing Bar 14 Carbon for Pin Indexing

Catalogue number P10107-610, 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

System WingSTEP High – Ball Joint

Catalogue number P10107-743, 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

HS PushPIN Basic Module Carbon

Catalogue number P10107-417, 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

WingSTEP Spare Part Set

(consisting of 2 ball joints for the WingSTEP baseplate, set of 2 polycarbonate screws and nuts for the arm and wrist support)

Accelerator, Linear, Medical

VacuumCushion 50×70

Vacuum Cushion, breast support, 50x70cm, 8L

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