System, Digital Image Communications, Radiological
Radiology · 21 CFR 892.2020
A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions.
Recent MDR events
168 adverse event reports on file
- OR1 NEO IP, ENH2 2.5Jul 31, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01738
- NAJul 27, 2026MalfunctionBlack Diamond Video, Inc.3008776287-2026-00455
- OR1 NEO IP, ENH2 2.5Jul 17, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01656
- OR1 NEO IP, ENH2 3.1.2.12Jul 16, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01646
- OR1 NEO IP, ENH2 3.1.0.10Jul 16, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01649
- OR1 NEO IP, ENH2 3.1.2.12Jul 16, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01644
- OR1 NEO IP, ENH2 3.1.0.10Jul 16, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01648
- OR1 NEO IP, ENH2 3.1.2.12Jul 16, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01645
- OR1 NEO IP, ENH2 3.1.2.12Jul 16, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01647
- OR1 NEO IP, ENH2 2.5Jul 7, 2026MalfunctionKarl Storz Se & Co. Kg9610617-2026-01551
Event type breakdown
Recalls
12 recall events for this product code
- CompView Medical, LLCTerminatedJan 13, 2016
Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing an
The attachment of the NuCART Spring Arm to the NuCART horizontal boom may come apart if the securing ring (snap ring) was not installed correctly causing the spring arm to release and detach.
Z-0644-2016 · View FDA record ↗ - Siemens Medical Solutions USA, IncTerminatedJun 2, 2015
syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration
A potential exists for order transactions from interfaced HIS (Hospital Information System) systems to be lost during a restart of interface processes when using the Order Batching feature, leading to diagnosis delay.
Z-1704-2015 · View FDA record ↗ - Karl Storz EndoscopyTerminatedJul 10, 2014
Essential NEO, Audio/Visual Integration Unit
KARL STORZ Endoscopy-America is recalling the Essential NEO because the connected power cable could potentially become overheated and result in smoke being generated and the cessation of function of the peripheral that the cable is connected to.
Z-2039-2014 · View FDA record ↗ - Ge Healthcare ItTerminatedDec 5, 2013
The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise
GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to DICOM Objects) interface allows for embedding DICOM images as JPEGs on a web page and is available as a licensed operation on Centricity Web. When rejected images are archived by Centricity PACS to Enterprise Archive, an
Z-0454-2014 · View FDA record ↗ - Stryker EndoscopyTerminatedJan 7, 2011
Stryker Digital Capture Pro 2 device (240-050-800, CD version) and (240-050-810, DVD version) designed for digital documentation of medical procedures. Manufac
Device will not able to assign the correct time/date stamp for saved filed after December 31, 2009. On Jan 1, 2010, the device system date for all SDC Pro 2 units will re-start from 1 Oct 2001 and begin incrementing from that point onwards. The system date will be incorrect and users will not be able to correct this issue. Problem will not affect how pictures or videos are captured using SDC Pro
Z-0867-2011 · View FDA record ↗ - GE Healthcare Integrated IT SolutionsTerminatedJan 12, 2009
Centricity Enterprise Web 3.0 software; the software allows physicians convenient, quick access to medical images and related data they need via a web browser,
Software error: There are two potential safety situations with Centricity Enterprise Web software - a forced log off may occur while using the Centricity Enterprise Web during an open session, and Centricity Enterprise Web does not utilize calibration performed on image measurements in Centricity RA1000 Workstation.
Z-0870-2009 · View FDA record ↗ - AGFA Corp.TerminatedJul 1, 2008
IMPAX 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to transfer medical imaging data. AGFA Corp., Greenville
Failure of Data Transmission: No imaging data could be transmitted by the device, because a key value needed for data transmission was incorrectly entered in the affected units by AGFA Healthcare.
Z-1306-2008 · View FDA record ↗ - Siemens Medical Solutions USA, IncTerminatedJun 5, 2007
Sienet MagicStore. Radiological Digital Image Communications System
System could crash and result in data loss.
Z-0890-2007 · View FDA record ↗ - Konica Minolta Medical Imaging USA, Inc.TerminatedNov 28, 2006
Konica Minolta PrintLink III Model - ID/IV, code no. 0770, 0771 Medical Imaging Communication Device
The power supply of a unit located in Japan overheated and caused a smoke condition and a small amount of flame coming off the unit.
Z-0220-2007 · View FDA record ↗ - Siemens Medical Solutions USA, IncTerminatedMay 16, 2003
MagicView 1000 and Magic View Mondo. Digital Image Communication.
Potential error can occur with the 3D post processing options MPR, MIP, and VRT.
Z-0840-03 · View FDA record ↗
Registered firms
151 firms currently registered for this product code
Treace Medical Concepts, Inc.
PONTE VEDRA, FL, US
Computer Md
Fort Lauderdale, FL, US
Intelerad Usa
Raleigh, NC, US
Arthrex Australia Pty Ltd.
Frenchs Forest New South Wales, AU
Carl Zeiss Meditec Ag (oberkochen)
OBERKOCHEN Baden-Wurttemberg, DE
Exo Imaging, Inc.
Santa Clara, CA, US
Barco S.r.l.
Saronno Varese, IT
Tribe Medical Group
London Ontario, CA
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Standard Imaging, Inc.
MIDDLETON, WI, US
Acula Technology Corp
Luchu Taoyuan, TW
Aiobio Co., Ltd.
Seongnam-si Gyeonggi, KR
Codonics, Inc.
Middleburg Heights, OH, US
Stryker Endoscopy
SAN JOSE, CA, US
Aycan Digitalsysteme Gmbh
WUERZBURG Bavaria, DE
Mevis Medical Solutions Ag
Bremen, DE
Sonio
Paris, FR
Icad Inc.
Nashua, NH, US
Medimaging Integrated Solution Inc.
Hsinchu Hsinchu (City), TW
Claripi Inc.
Seoul, KR
Hologic, Inc.
Newark, DE, US
Barco (suzhou) Healthcare Technology Co., Ltd.
Suzhou Jiangsu, CN
Arvato Se
Hamburg, DE
Graphic Controls Acquisition Corp.dba Nissha Medical Technologies
BUFFALO, NY, US
Icometrix
Leuven Vlaams Brabant, BE
510(k) clearances
142 clearances for this product code
- Terarecon,Inc.May 26, 2000
K994329 · IIVS INTEGRATED IMAGE VIEWING STATION
- Stentor, Inc.Oct 25, 1999
K992698 · STENTOR, PAGEVIEW
- Samsung Sds Co., Ltd.Oct 13, 1999
K992426 · RAYPAX WEB CLINICAL SYSTEM
- Inteleradiology, Inc.Sep 29, 1999
K992352 · ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0
- Samsung Sds Co., Ltd.Jul 6, 1999
K991537 · SAMSUNG RAYPAX SYSTEM
- Surgical Navigation Technologies, Inc.Jan 12, 1999
K984000 · STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM
- Visual Med, Inc.Jul 31, 1998
K974707 · IMAGEQUEST
- Eastman Kodak CompanyJun 18, 1998
K981053 · KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW