AccuCheck

Primary DI
06973127400111
Brand
AccuCheck
Company
Manteia Technologies Co.,Ltd.
Model
1.2
Device description
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.
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250696000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250696000AccuCheckManteia Technologies Co., Ltd.2025-10-24IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973127400111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973127400111069731274001116973127400111

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy softwareAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Regulatory Flags#

DUNS number
416535464
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973127400098AccuContour4.02026-04-27
06973127400135ARTAssistant1.12026-04-22
06973127400029AccuContourAccuContour2025-06-16
06973127400012AccuContour1.1.02020-06-22
06973127400050AccuContour3.1.02023-04-01
06973127400043AccuCheck1.12023-11-06
06973127400067MOZI TPS1.32023-11-06
16973127400019AccuContour1.1.02020-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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