Aycan Workstation Osirix Pro
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K103546 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aycan Workstation Osirix Pro is a medical imaging workstation designed for advanced diagnostic interpretation and post-processing of radiological images. It leverages the Osirix platform to enable comprehensive analysis, annotation, and sharing of DICOM-compatible medical imaging data, supporting modalities such as CT, MRI, and X-ray.
This workstation is supplied as a software-based solution integrated with hardware components, intended for use in radiology departments, diagnostic imaging centers, and clinical settings. It operates under FDA 510(k) clearance (K103546) and EU MDR compliance, requiring installation on compatible medical-grade computers. The system is non-sterile, reusable, and does not contain MRI-safe components, as it is designed for external diagnostic interpretation rather than direct patient interaction.
Frequently asked questions
What types of medical imaging data can the Aycan Workstation Osirix Pro analyze and process?
The Aycan Workstation Osirix Pro is designed to analyze and process DICOM-compatible radiological images from multiple modalities, including CT scans, MRI, and X-rays. This makes it suitable for comprehensive diagnostic interpretation and post-processing tasks in radiology departments and imaging centers.
Is the Aycan Workstation Osirix Pro a standalone device, or does it require installation on a specific type of hardware?
The Aycan Workstation Osirix Pro is a software-based solution that must be installed on compatible medical-grade computers. It is not a standalone device but rather an integrated system requiring proper hardware infrastructure for operation.
Can the Aycan Workstation Osirix Pro be reused across multiple patients, and what are its sterility considerations?
The Aycan Workstation Osirix Pro is explicitly labeled as non-sterile and reusable. Since it is designed for diagnostic interpretation and post-processing of images—rather than direct patient contact—sterility is not a requirement. However, proper hygiene practices for the hardware it runs on should still be followed.
What regulatory pathways does the Aycan Workstation Osirix Pro follow, and how does this affect its use in different regions?
The device holds FDA 510(k) clearance (K103546) under a special review pathway, indicating it is deemed substantially equivalent to a predicate device. It also complies with EU MDR requirements, allowing its use in both the U.S. and EU markets. These clearances ensure it meets regulatory standards for diagnostic imaging workstations in those regions.
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
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 | K103546 | Class II | Active |
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Manufacturer
- Manufacturer
- Aycan Digitalsysteme Gmbh
Sources (2)
- FDA 510(k) K103546 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026