AccuContour

GUDID 16973127400019

It is used by radiation oncology department to register multimodality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.

Manteia Technologies Co.,Ltd.

Radiology DICOM image processing application software

• Primary Device ID: 16973127400019
• NIH Device Record Key: 19746013-278d-4d95-ac89-ab317373986f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuContour
• Version Model Number: 1.1.0
• Company DUNS: 416535464
• Company Name: Manteia Technologies Co.,Ltd.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	06973127400012 [Primary]
GS1	16973127400019 [Package]; Contains: 06973127400012; Package: box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191928

FDA Product Code

• QKB: Radiological Image Processing Software For Radiation Therapy

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: 2020-06-30
• Device Publish Date: 2020-06-22

On-Brand Devices [AccuContour]

• 16973127400019: It is used by radiation oncology department to register multimodality images and segment (non-co
• 06973127400050: It is used by radiation oncology department to register multi-modality images and segment (non-c