AI-Rad Companion Organs RT
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- AI-Rad Companion Organs RT EUDAMEDFDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_O-RT EUDAMED
- Model / Reference
- MDR_VD_IIb_ERLN_H_127_SAMD_AIRC_O-RT EUDAMED11830482 EUDAMED11823875 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04068151034189 EUDAMED04068151010404 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686902011UN EUDAMED
- 510(k) Number
- K242745 FDA UDI
- FDA Product Code
- QKB FDA UDI
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The AI-Rad Companion Organs RT is an AI-powered medical imaging device designed for automated contouring of organs at risk. Classified under nomenclature code Z11069092 as a Class IIb diagnostic imaging device, it leverages deep learning algorithms to generate high-quality anatomical delineations. These contours are intended for use in radiotherapy treatment planning systems, supporting precision oncology workflows. The device operates as a standalone software application integrated into existing imaging and treatment planning environments.
AI-Rad Companion Organs RT is supplied as a non-sterile, single-use software solution for use in radiology and oncology departments. It is not implantable, reprocessable, or associated with latex or animal-derived materials. The device is authorized under FDA 510K and MDR compliance frameworks, with a unique UDI (0405686902011UN) for traceability. Storage and usage require compatibility with DICOM-based imaging systems, and its application is limited to contouring organs at risk for radiotherapy planning, without direct patient administration or medicinal intervention.
Frequently asked questions
What is the primary purpose of the AI-Rad Companion Organs RT in a radiotherapy workflow?
The AI-Rad Companion Organs RT is designed to automate the contouring of organs at risk during radiotherapy treatment planning. By using deep learning algorithms, it generates precise anatomical delineations that improve the accuracy and efficiency of planning systems, ultimately supporting safer and more effective precision oncology treatments.
Is the AI-Rad Companion Organs RT a reusable or implantable device, and what are its sterility and material considerations?
The AI-Rad Companion Organs RT is a non-sterile, single-use software solution and is not implantable. It contains no animal-derived materials or latex, and it is not intended for reprocessing or direct patient administration. Its use is confined to radiology and oncology departments for contouring purposes only.
How is the AI-Rad Companion Organs RT integrated into existing medical imaging systems, and what compatibility requirements must be met?
The AI-Rad Companion Organs RT operates as a standalone software application that integrates with DICOM-based imaging systems and radiotherapy treatment planning environments. Compatibility with these systems is essential for its functionality, as it relies on existing infrastructure to process and output organ contours for planning.
What regulatory pathways does the AI-Rad Companion Organs RT follow, and how does this affect its traceability?
The device is authorized under both FDA 510K and MDR (Medical Device Regulation) compliance frameworks. It includes a unique UDI (0405686902011UN) for traceability, ensuring compliance with global regulatory requirements and enabling clear identification in clinical and administrative records.
Does the AI-Rad Companion Organs RT require any special storage conditions, and how is it supplied?
The AI-Rad Companion Organs RT is supplied as a non-sterile, single-use software solution and does not require specialized storage beyond standard IT and system compatibility. Since it is not a physical device, storage focuses on ensuring the software remains compatible with DICOM-based systems and radiotherapy planning software environments.
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: AI-Rad Companion - Siemens Healthineers, AI-Rad Companion Organs RT | Siemens Healthineers | Cancer Care - Varian, AI-Rad Companion Organs RT - Siemens Healthineers, AI-Rad Companion Organs RT - Siemens Healthineers
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242745 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K252548 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 0405686902011UN | Class IIb | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare GmbH
- EUDAMED SRN
- DE-MF-000006122
Sources (4)
- EUDAMED d661fd5c-02f3-4092-9eef-aa7f552c87af 61 fields · synced Oct 6, 2026
- EUDAMED f54f016d-6246-4f93-aa5f-feff1614de1a 61 fields · synced May 18, 2026
- FDA UDI c853c829-9f83-4b6d-a142-c05a49e12115 34 fields · synced May 30, 2026
- FDA 510(k) K242745 1 fields · synced May 18, 2026