AccuCheck

AccuCheck, defined as a radiotherapy plan quality assurance system, aims to improve the clinical efficiency of offline and online quality control. AccuCheck supports Monte Carlo dose…

Registry build 21.09.26

AccuCheck, defined as a radiotherapy plan quality assurance system, aims to improve the clinical efficiency of offline and online quality control. AccuCheck supports Monte Carlo dose calculation engine, and is applicable to the quality assurance of general offline planning, online adaptive planning and various radiotherapy technology such as photon and proton. AccuCheck is to be used for the quality assurance of offline plans and online adaptive radiotherapy plans, where the TPS Check module is used to check whether the parameters related to treatment plan are within the executable range of the machine; the Dose Check module is designed to use an independent dose calculation engine to re-calculate the original plan before the treatment, and is compared with the dose of the original plan; the Transfer Check module could verify whether errors are occurred during transferring from the TPS system to the accelerator; the Log Check module is used to obtain execution log of each execution of the accelerator, calculate dose through an independent dose calculation engine, and compare it with the dose of original plan; Treatment Summary supports physical dose accumulation of doses executed multiple times for a single plan, which reflect the stability of the accelerator operating, it could at the same time support the reconstruction of log to the fractional images so as to evaluate the daily exposure dose of the patient. AccuCheck provides abundant auxiliary analysis tools, including DVH Graph, Gamma Analysis, Target Coverage, Gamma Pass Rate of each ROI, Dose Statistics, and Clinical Goals Evaluation.

8manufacturers in China registered for this device type
2catalogue numbers in this listing
3510(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 AccuCheck
Listed by Manteia Technologies Co., Ltd., China
FDA product code IYE
Device type Accelerator, Linear, Medical
Device class Class 2
Regulation 21 CFR 892.5050
Establishment Manufacturer
510(k) K223834
Record published 2023-11-06

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for AccuCheck
Catalogue number Size Status
1.1 In distribution
1.2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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Accelerator, Linear, Medical PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 71
Thermoplastic Mask IZI Medical Products LLC 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
K260733 2026-08-26
K250696 2025-10-24
K223834 2023-07-20

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