Identity
- Trade Name
- SciMoCa EUDAMEDFDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- SciMoCa EUDAMEDSciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa 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
- v1.x EUDAMED1.x FDA UDI
- Description
- SciMoCa is a standalone software product that allows clinicians to perform quality assurance of a radiotherapy treatment dose generated by a treatment planning system via recalculation of the dose with an independent Monte Carlo dose calculation algorithm. SciMoCa is implemented in a service-oriented client-server architecture that allows one or more clients to communicate calculation requests to a central dose calculation server. SciMoCa 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
- 00863284000315 EUDAMEDFDA UDI
- Basic UDI-DI
- 08632840003SciMoCa88 EUDAMED
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Radiation therapy software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Austria 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
Yes
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
Yes
FDA UDI
Category: Device sterilization/disinfection container, reusable
SciMoCa by Radialogica Llc — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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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 | K180595 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08632840003SciMoCa88 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Radialogica LLC
- EUDAMED SRN
- US-MF-000037527
- FDA Applicant
- Radialogica, LLC
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (3)
- EUDAMED 79fc3747-29c6-44b2-8ce7-e2ff6aab3e64 85 fields · synced Jun 18, 2026
- FDA UDI 1b9b0ca6-f8e7-4f64-a2d1-62c144257471 34 fields · synced May 30, 2026
- FDA 510(k) K180595 1 fields · synced May 18, 2026