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AccuContour
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref AC0029Model AccuContour
Identity
- Trade Name
- AccuContour EUDAMEDFDA 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 EUDAMEDFDA UDIAC0029 EUDAMED
- 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
- 06973127400029 EUDAMEDFDA UDI
- Basic UDI-DI
- 697312740AccuContourXE EUDAMED
- Direct Marketing DI
- 06973127400029 EUDAMED
- 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
AccuContour by Manteia Technologies Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221706 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697312740AccuContourXE | Class IIa | Active |
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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 (3)
- EUDAMED 8c078f7e-ad37-4aa4-96bd-f6687ccdbfef 61 fields · synced Jul 9, 2026
- FDA UDI 8cf510d8-8f28-4773-b043-e23a0e80147f 35 fields · synced May 30, 2026
- FDA 510(k) K221706 1 fields · synced May 18, 2026