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AccuCheck
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 0043Model AccuCheck510(k) K223834
Identity
- Trade Name
- AccuCheck EUDAMEDFDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- AccuCheck EUDAMEDAccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on LINAC delivery log after radiotherapy plan execution. AccuCheck is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes. FDA UDI
- Model / Reference
- AccuCheck EUDAMED0043 EUDAMED1.1 FDA UDI
- Description
- AccuCheck is a quality assurance software used for data transfer integrity check, secondary dose calculation with Monte Carlo algorithm, and treatment plan verification in radiotherapy. AccuCheck also provides independent dose verification based on LINAC delivery log after radiotherapy plan execution. AccuCheck is not a treatment planning system or a radiation delivery device. It is to be used only by trained radiation oncology personnel for quality assurance purposes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973127400043 EUDAMEDFDA UDI
- Basic UDI-DI
- 697312740ACCUCHECKAF EUDAMED
- 510(k) Number
- K223834 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010492 RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiation therapy software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 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
AccuCheck by Manteia Technologies Co., Ltd. — Class IIb — 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
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 | K223834 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K250696 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 697312740ACCUCHECKAF | Class IIb | 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 2cdf0b42-bec9-47f5-b418-02dce4e2cc7b 85 fields · synced Jun 19, 2026
- FDA UDI cdbcecb2-930d-4ce6-af0a-95262a4cb3e5 34 fields · synced May 30, 2026
- FDA 510(k) K223834 1 fields · synced May 18, 2026