Identity
- Trade Name
- AccuContour FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 1.1.0 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973127400012 FDA UDI
- 510(k) Number
- K191928 FDA UDI
- FDA Product Code
- QKB FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology DICOM image processing application software
AccuContour by Manteia Technologies Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Manteia Technologies Co., Ltd.
Sources (1)
- FDA UDI 19746013-278d-4d95-ac89-ab317373986f 34 fields · synced May 30, 2026