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AccuContour-Lite
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AC0050Model AccuContour-Lite
Identity
- Trade Name
- AccuContour-Lite EUDAMEDAccuContour FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- AccuContour AI-assisted Auto-contouring Tool EUDAMEDIt 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. FDA UDI
- Model / Reference
- AccuContour-Lite EUDAMEDAC0050 EUDAMED3.1.0 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973127400050 EUDAMEDFDA UDI
- Basic UDI-DI
- 697312740AccuContourLTQ3 EUDAMED
- Direct Marketing DI
- 06973127400050 EUDAMED
- 510(k) Number
- K221706 FDA UDI
- FDA Product Code
- QKB FDA UDI
- EMDN Code
- Z11010492 RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
AccuContour-Lite by Manteia Technologies Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697312740AccuContourLTQ3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Manteia Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000023911
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 846c5234-23a9-4fb8-b146-5d64b35e2921 61 fields · synced Jul 9, 2026
- FDA UDI 6036dbb6-c5d7-4c96-850c-2225fc485d66 34 fields · synced May 30, 2026