Aycan Workstation Osirix
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K063470 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 is a medical imaging workstation designed for the interpretation and analysis of radiological images. It integrates advanced diagnostic tools to enhance visualization and post-processing of digital imaging data, supporting radiologists and clinicians in accurate diagnostic assessments.
This workstation is supplied as a software-based solution for use in radiology departments and imaging centers. It operates on standard hardware platforms and is intended for single-user, non-sterile applications. The device is authorized under FDA 510(k) clearance (K063470) and complies with the EU Medical Device Regulation (MDR), ensuring adherence to regulatory standards for medical imaging software.
Frequently asked questions
What types of radiological images can the Aycan Workstation Osirix analyze and visualize?
The Aycan Workstation Osirix is designed for the interpretation and analysis of radiological images, including those from digital imaging modalities. While the exact modalities aren’t specified, its advanced diagnostic tools are intended to enhance visualization and post-processing of common imaging data such as CT scans, MRIs, X-rays, and other digital radiology formats. This makes it suitable for radiologists and clinicians working in radiology departments or imaging centers.
Is the Aycan Workstation Osirix a standalone device, or does it require specific hardware to operate?
The Aycan Workstation Osirix is supplied as a software-based solution and is intended to operate on standard hardware platforms. This means it is not a physical appliance but rather an application that runs on compatible computers or workstations within a radiology department or imaging center. The software integrates with existing systems to provide diagnostic tools for image analysis.
How is the Aycan Workstation Osirix regulated, and what does that mean for its use in clinical settings?
The device holds FDA 510(k) clearance (K063470) under the Traditional review pathway, with a decision classification of *Substantially Equivalent* to a predicate device, and complies with the EU Medical Device Regulation (MDR). This means it has undergone regulatory review to ensure safety and performance for its intended use in radiology departments, but it does not imply any specific clinical indication—only that it meets regulatory standards for medical imaging software.
Can multiple users access the Aycan Workstation Osirix simultaneously, or is it intended for single-user use?
The device is explicitly designed for single-user, non-sterile applications in radiology departments or imaging centers. This means one clinician at a time will operate the software on a dedicated workstation, ensuring proper workflow and accountability for diagnostic assessments. It is not intended for shared or multi-user environments.
What kind of maintenance or updates are expected for the Aycan Workstation Osirix, and how is it typically deployed?
As a software-based solution, the Aycan Workstation Osirix likely requires periodic software updates to maintain functionality, security, and compatibility with evolving imaging standards. Deployment typically involves installation on pre-approved hardware within a clinical setting, with potential for remote updates or support from the manufacturer (Aycan Digitalsysteme GmbH). No physical maintenance is required beyond standard IT upkeep of the host system.
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 | K063470 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aycan Digitalsysteme Gmbh
Sources (2)
- FDA 510(k) K063470 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 3, 2026