Identity
- Trade Name
- Mobius3D EUDAMEDFDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- Mobius3D EUDAMED
- Model / Reference
- Mobius3D 4.1 EUDAMED4.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850800006050 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500200115PM EUDAMED
- 510(k) Number
- K250099 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010482 RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - SOFTWARE ACCESSORIES 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
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
The Mobius3D 4.1 is a Radiation Therapy Planning System (Nomenclature Code: Z11010482), designed for advanced treatment planning in radiotherapy. It integrates 3D imaging and dose calculation algorithms to optimize patient-specific radiation therapy protocols, supporting complex treatment modalities such as intensity-modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT).
Mobius3D 4.1 is supplied as a software application for use on compatible radiotherapy treatment planning workstations, requiring no sterilization or reprocessing. It operates in clinical radiation oncology settings and is classified as a Class IIb medical device under regulatory frameworks, including FDA 510(k) clearance and MDR compliance. The system is non-reusable, non-sterile, and non-implantable, with a unique Device Identifier (DI) code of 00850800006050.
Frequently asked questions
What is the primary purpose of the Mobius3D 4.1 system in a clinical setting?
The Mobius3D 4.1 is designed specifically for advanced radiation therapy planning. It integrates 3D imaging and sophisticated dose calculation algorithms to optimize patient-specific treatment protocols, particularly for complex modalities like intensity-modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT). This ensures precise targeting of radiation while minimizing exposure to healthy tissue.
How is the Mobius3D 4.1 supplied and does it require any special handling?
The Mobius3D 4.1 is supplied as a software application for radiotherapy treatment planning workstations. Since it is non-sterile (sterility status: 0) and non-reusable (reusable status: 0), it does not require sterilization or reprocessing. It is intended for single-use in clinical settings, though the software itself can be installed and utilized repeatedly across multiple patients on compatible hardware.
Is the Mobius3D 4.1 compatible with other medical devices or systems in a radiotherapy workflow?
The Mobius3D 4.1 is a standalone software solution designed to integrate with radiotherapy treatment planning workstations. While the data does not specify direct compatibility with other devices, its role in optimizing IMRT and VMAT suggests it is intended to work within existing radiotherapy workflows that rely on 3D imaging and dose calculation systems. Compatibility would depend on the specific hardware and software infrastructure of the facility.
What regulatory pathways has the Mobius3D 4.1 undergone, and how does this affect its use?
The Mobius3D 4.1 has obtained FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR). These pathways confirm that the system meets the necessary safety, performance, and quality standards for use in clinical radiation oncology settings. The classification as a Class IIb device further indicates it undergoes rigorous evaluation to ensure its effectiveness and safety in advanced radiotherapy planning.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250099 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K191761 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K203669 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K192424 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 089947500200115PM | Class IIb | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (3)
- EUDAMED f36b18ac-99f1-4ffb-a2b2-2983419c9f3e 61 fields · synced Sep 18, 2026
- FDA UDI 9370dbf1-ddf2-400d-b173-258618eb72ed 33 fields · synced May 30, 2026
- FDA 510(k) K250099 1 fields · synced May 18, 2026