Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016686005

FEI Number

3016686005

Entity Name

MANTEIA TECHNOLOGIES CO.,LTD.

City/State/Country

Xiamen Fujian, CN

Establishment Address

Unit 3001-3005, No.5 Huizhan North Road, Xiamen Fujian 361000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Manteia Technologies Co.,Ltd. (Owner Number: 10062831)

Owner / Operator Contact Address

Unit 3001-3005, No.5 Huizhan North Road, Xiamen, CN-FJ 361000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191928

PMA Number

N/A

All Registered Proprietary Names

AccuCheck Radiotherapy Plan Quality Assurance System AccuCheck AccuContour 4 AccuContour ARTAssistant AccuCheck MOZI TPS AccuContour

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2023-07-21
QKB	Radiological Image Processing Software For Radiation Therapy	Radiology	Class 2	892.2050	2026-04-22
QKB	Radiological Image Processing Software For Radiation Therapy	Radiology	Class 2	892.2050	2023-03-24
QKB	Radiological Image Processing Software For Radiation Therapy	Radiology	Class 2	892.2050	2025-12-22
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2025-11-25
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2023-07-13
QKB	Radiological Image Processing Software For Radiation Therapy	Radiology	Class 2	892.2050	2020-03-11

Official Correspondent

Chao Fang

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Manteia Technologies Co.,Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K071992	Varian Medical Systems	HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)	2007-08-15
K253962	Radformation, Inc.	ClearCheck (RADCC V2.7)	2026-04-03
K003779	Arplay Medical S.A.	IMMOBILIZATION SYSTEM FOR ENT	2001-07-12
K993675	Nomos Corp.	PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM	2000-09-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2019	Varian Medical Systems	2	TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019	Varian Medical Systems	2	VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015	N/A	2	Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

Similar Registrations

Registration Number	Establishment Name	Location
3014113695	JIANGSU RAYER MEDICAL TECHNOLOGY CO., LTD.	Wuxi Jiangsu, CN
1722661	RADIOLOGICAL IMAGING TECHNOLOGY, INC.	Co Spgs, CO, US
3030077501	CHABNER XRT, LLC	Port Chester, NY, US
3007791541	Varian Medical Systems China Co., Ltd.	Beijing, CN
1932738	MEDTEC LLC	Orange City, IA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016686005. Last updated year: 2026. Please use registration number 3016686005 when referencing this establishment in official correspondence.