AccuCheck

GUDID 06973127400043

AccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on LINAC delivery log after radiotherapy plan execution. AccuCheck is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.

Manteia Technologies Co.,Ltd.

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• Primary Device ID: 06973127400043
• NIH Device Record Key: cdbcecb2-930d-4ce6-af0a-95262a4cb3e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuCheck
• Version Model Number: 1.1
• Company DUNS: 416535464
• Company Name: Manteia Technologies Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973127400043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223834

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-14
• Device Publish Date: 2023-11-06

Devices Manufactured by Manteia Technologies Co.,Ltd.

• 06973127400043 - AccuCheck: 2023-11-14AccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on LINAC delivery log after radiotherapy plan execution. AccuCheck is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes.
• 06973127400043 - AccuCheck: 2023-11-14 AccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo al
• 06973127400067 - MOZI TPS: 2023-11-14 The MOZI Treatment Planning System (MOZI TPS) is used to plan radiotherapy treatments for patients with malignant or benign dise
• 06973127400050 - AccuContour: 2023-04-10 It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate
• 16973127400019 - AccuContour: 2020-06-30 It is used by radiation oncology department to register multimodality images and segment (non-contrast) CT images, to generate n