System, Digital Image Communications, Radiological
Regulation 892.2020
0510(k)s in 12 months (142 all time)
0recalls in 12 months (12 all time)
3recalls that name a 510(k)
Top companies in LMD
| Company | 510(k)s | Recalls |
|---|---|---|
| Dejarnette Research Systems | 7 | 0 |
| Eastman Kodak Company | 7 | 0 |
| Siemens Medical Solutions USA, Inc. | 2 | 3 |
| Vortech Data, Inc. | 5 | 0 |
| Image Data Corp. | 4 | 0 |
| Merlin Engineering Works, Inc. | 4 | 0 |
| Advanced Video Products, Inc. | 3 | 0 |
| Evergreen Technologies, Inc. | 3 | 0 |
| Olicon Imaging Systems, Inc. | 3 | 0 |
| Siemens Gammasonics, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2020 | Skytron, Div. The KMW Group, Inc VGDF-SKY (R4-010-06) VGA TO FIBER CONVERTER-Single Format Faceplate, a component of the SkyVision Linx 300 Integration Control System
Model: VGDF-SKY (version 2). For communication and visual image m Terminated |
LMD | None listed |
| Mar 10, 2020 | Skytron, Div. The KMW Group, Inc SkyVision SDS System - Video Integration
Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit for use in the operating room. Terminated |
LMD | None listed |
| Jan 13, 2016 | CompView Medical, LLC Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals fro Terminated |
LMD | None listed |
| Jun 2, 2015 | Siemens Medical Solutions USA, Inc syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and Terminated |
LMD | None listed |
| Jul 10, 2014 | Karl Storz Endoscopy Essential NEO, Audio/Visual Integration Unit
An audio/visual integration unit. Terminated |
LMD | None listed |
| Dec 5, 2013 | Ge Healthcare It The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribu Terminated |
LMD | None listed |
| Jan 7, 2011 | Stryker Endoscopy Stryker Digital Capture Pro 2 device (240-050-800, CD version) and (240-050-810, DVD version) designed for digital documentation of medical procedures. Manufactured by Stryker Endoscopy, San Jose, CA Terminated |
LMD | None listed |
| Jan 12, 2009 | GE Healthcare Integrated IT Solutions 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, password and a standard PC; GE Healthcar Terminated |
LMD | None listed |
| Jul 1, 2008 | AGFA Corp. 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, South Carolina 2960. Terminated |
LMD | None listed |
| Jun 5, 2007 | Siemens Medical Solutions USA, Inc Sienet MagicStore. Radiological Digital Image Communications System Terminated |
LMD | K920310 |
| Nov 28, 2006 | Konica Minolta Medical Imaging USA, Inc. Konica Minolta PrintLink III Model - ID/IV, code no. 0770, 0771 Medical Imaging Communication Device
Model IV - product code 5000230
Model ID, product code 5000330
Konica Minolta Medical & Graphi Terminated |
LMD | K900227 |
| May 16, 2003 | Siemens Medical Solutions USA, Inc MagicView 1000 and Magic View Mondo. Digital Image Communication. Terminated |
LMD | K935694 |
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