Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003895711

FEI Number

3003895711

Entity Name

AYCAN DIGITALSYSTEME GMBH

City/State/Country

WUERZBURG Bavaria, DE

Establishment Address

INNERE AUMUEHL STRASSE 5, WUERZBURG Bavaria 97076, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AYCAN DIGITALSYSTEME GMBH (Owner Number: 9051337)

Owner / Operator Contact Address

INNERE AUMUEHL STRASSE 5, --, WUERZBURG, DE-BY 97076, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K103546

PMA Number

N/A

All Registered Proprietary Names

aycan xray-print AYCAN X-RAY PRINT SYSTEMS aycan store aycan mobile aycan workstation PRO aycan OsiriX PRO aycan workstation OsiriX PRO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2002-09-02
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2009-12-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2012-10-15
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2011-10-07

Official Correspondent

Matthias Broenner

US Agent Details

Dennis van Keken Business: aycan Medical Systems LLC Email: dvankeken@aycan.com Phone: (585) 4731350

Related Public Records

Same Entity

AYCAN DIGITALSYSTEME GMBH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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3010956703	Visual Medica	Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, AR
3006619220	Canon Medical Informatics A/S	Valby Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003895711. Last updated year: 2026. Please use registration number 3003895711 when referencing this establishment in official correspondence.