Aycan Mobile
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- aycan mobile EUDAMEDFDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- aycan PACS EUDAMED
- Model / Reference
- aycan mobile EUDAMEDv1 (US) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260476510038 EUDAMEDFDA UDI
- Basic UDI-DI
- 42604765aycanPACSHA EUDAMED
- Direct Marketing DI
- 04260476510038 EUDAMED
- 510(k) Number
- FDA Product Code
- LLZ FDA 510(k)FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)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
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
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Aycan Mobile is a radiological image viewer (Product Code: LLZ) designed for the evaluation and processing of digital medical images. It enables advanced functions such as window level and width adjustments, region-of-interest (ROI) analysis, voice dictation, and multi-series comparison, supporting modalities including X-ray (CR), computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), and 3D volume rendering (3D-VR).
The device is supplied as a software application for iPad, requiring installation via the App Store alongside an active user account with subscription or linked access. It operates in radiology settings and is classified under the FDA 510(k) clearance (K122260) and MDR regulatory framework. No sterility or single-use requirements are specified, and MRI safety is not addressed in the provided data.
Frequently asked questions
What types of medical images can the AYCAN MOBILE viewer process and analyze?
The AYCAN MOBILE is designed to evaluate and process digital images from multiple radiological modalities, including X-ray (CR), computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US), and 3D volume rendering (3D-VR). Its advanced features like window level/width adjustments and region-of-interest (ROI) analysis make it versatile for reviewing these image types in radiology workflows.
How is the AYCAN MOBILE supplied, and what system requirements are needed to use it?
AYCAN MOBILE is supplied as a software application exclusively for iPad devices. It must be installed via the App Store and requires an active user account with either a subscription or linked access. No additional hardware or sterility requirements are specified, as it operates purely as a digital tool.
Is the AYCAN MOBILE intended for single-use or repeated use in clinical settings?
The device is not specified as single-use or requiring sterility, as it functions as a software application on a mobile platform. This means it can be reused across multiple patients and sessions without disposal or reprocessing, provided the iPad and account remain functional.
What regulatory pathways has the AYCAN MOBILE followed for market authorization?
The device has obtained FDA clearance through a traditional 510(k) process (K122260) and is also authorized under the EU’s Medical Device Regulation (MDR). The classification under FDA Product Code LLZ (Radiology) and the advisory committee review by RA (Radiology) confirm its regulatory standing for use in radiological image evaluation.
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: aycan mobile Teleradiologie - aycan Digitalsysteme GmbH, aycan mobile iPad App - aycan Medical Systems, Welcome | aycan mobile, aycan mobile on the App Store
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 | K122260 | Class II | Active |
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Manufacturer
- Manufacturer
- Aycan Digitalsysteme Gmbh
Sources (3)
- FDA 510(k) K122260 24 fields · synced Oct 6, 2026
- FDA UDI 507f396f-335f-4e45-b4ef-2a7c6afbe9c0 33 fields · synced May 29, 2026
- EUDAMED 2e8e92d5-ffe2-4916-a7c5-991aa4ceb75b 61 fields · synced Jul 20, 2026