RT Elements - RT Elements (4.5)
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Brainlab AG
Identity
- Trade Name
- RT Elements, 4.5 EUDAMEDRT Elements FDA UDI
- Generic Name
- Radiation therapy software FDA UDI
- Device Name
- RT Elements EUDAMED
- Model / Reference
- 04056481146030 EUDAMED4.5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481146030 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481RTElementsW8 EUDAMED
- Direct Marketing DI
- 04056481146030 EUDAMED
- 510(k) Number
- FDA Product Code
- MUJ FDA 510(k)FDA UDIQIH FDA UDI
- EMDN Code
- Z11010492 RADIOTHERAPY TREATMENT PLANNING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiation therapy software FDA UDI
- Models / Variants
- RT Elements (4.5) FDA 510(k)FDA UDIEUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)FDA UDI892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
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
No
RT Elements is a software suite for radiation therapy (RT) treatment planning, designed under the OpenFDA classification as a System, Planning, Radiation Therapy Treatment device. It integrates multiple specialized modules—including stereotactic radiosurgery (SRS) tools for brain metastases, cranial and spine applications, and advanced segmentation and dose review functionalities—to support precise target delineation, adaptive planning, and treatment optimization across various anatomical regions.
The system is supplied as a digital software platform, intended for use in radiology departments and radiation oncology clinics. It operates as a reusable, non-sterile solution with no MRI safety considerations specified. Modules cover indications such as cranial, basal ganglia, head & neck, pelvic, and extracranial regions, with AI-assisted tumor segmentation and smart brush tools for enhanced workflow efficiency. Authorized under FDA 510(k) and MDR compliance, it adheres to regulatory standards for radiation therapy planning systems.
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. Sources consulted: RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements ..., Elements: Radiotherapy & Radiosurgery Treatment Planning | Brainlab, RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K250440 | Class II | Active |
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Manufacturer
- Manufacturer
- Brainlab AG
Sources (3)
- FDA 510(k) K250440 24 fields · synced Sep 18, 2026
- FDA UDI e6c53577-e093-4cdf-bb59-9bde37dfdcd9 33 fields · synced May 30, 2026
- EUDAMED dc38133b-496a-4cd4-b693-aee6e3ee50e0 61 fields · synced Jul 9, 2026