AccuContour

GUDID 06973127400029

It is used by radiation oncology department to register multi-modality 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: 06973127400029
• NIH Device Record Key: 8cf510d8-8f28-4773-b043-e23a0e80147f
• Commercial Distribution Discontinuation: 2025-06-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AccuContour
• Version Model Number: AccuContour
• 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: true
• 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	06973127400012 [Previous]
GS1	06973127400029 [Primary]

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: 2025-06-24
• Device Publish Date: 2025-06-16

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
• 06973127400029: It is used by radiation oncology department to register multi-modality images and segment (non-c