ClearanceBrief
Panels › Radiology › Product code LLZ · Class 2

System, Image Processing, Radiological

Regulation 892.2050

50510(k)s in 12 months (2,297 all time)
25recalls in 12 months (562 all time)
544recalls that name a 510(k)
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Top companies in LLZ

Company510(k)sRecalls
Siemens AG Medical Solutions9589
GE Healthcare2384
Merge Healthcare Incorporated661
Carestream Health, Inc.953
Vital Images, Inc.3410
Agfa Corp.634
Totoku Electric Co., Ltd.400
Barco N.V.370
Eizo Nanao Corporation340
Ewoosoft Co., Ltd.290
DateFirm and productCodeLinked 510(k)
Jun 27, 2008AGFA Corp.
Agfa HeartLab Cardiovascular DICOMstore Version 2.04.40.00 software, Heartlab, Inc., Westerly, Rhode Island 02891. The software is used in the Agfa HeartLab Cardiovascular System.
Terminated		 LLZK050228
May 28, 2008Emageon
EVMS (Enterprise Visual Medical System); Picture archiving and communications system; Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and 7.0.0.1. Emageon, Inc., Hartland, WI 53029.
Terminated		 LLZK053281
May 20, 2008Siemens Medical Solutions USA, Inc.
syngo US Workplace Picture Archiving and Communication System, software version 2.0, Siemens Medical Solutions, Inc., Mountain View, CA 94043
Terminated		 LLZK060992
May 8, 2008Philips Healthcare Informatics, Inc.
iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Healthcare Informatics, Foster City, CA 94404.
Terminated		 LLZK042292
May 1, 2008GE Healthcare Integrated IT Solutions
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
Terminated		 LLZK043415
Apr 29, 2008Siemens Medical Solutions USA, Inc
Leonardo Workstation Picture Archiving and Communication System, Model Number: 7129534, Software Version: VB30B, Siemens Medical Solutions, Inc., Malvern, PA 19355
Terminated		 LLZK040970
Mar 31, 2008AGFA Corp.
Agfa IMPAX CardioVascular Suite Results Management Nuclear Reporting Module, Outbound Report, Model/Catalog No.: L7W1P, Software Versions: 2.04.17, 2.04.19 and 2.04.20, AGFA HealthCare, Westerly, RI
Terminated		 LLZK050228
Feb 23, 2008Siemens Medical Solutions USA, Inc
Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Siemans Medical Solutions, Malvern, PA 19355
Terminated		 LLZK071114
Jan 31, 2008Vital Images, Inc.
Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images, Inc., 5850 Opus Parkway, Suite 300, Minnetonka, MN 55343. ( A web-based medical diagnostic tool that allow
Terminated		 LLZK062154
K071362
Jan 23, 2008GE OEC Medical Systems, Inc
GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, GE Healthcare, Surgery, Salt Lake City, UT 84116
Terminated		 LLZK960330
Nov 28, 2007GE Healthcare
GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Worksation 4.4 with Volu
Terminated		 LLZK020483
K052995
Nov 10, 2007GE OEC Medical Systems, Inc
GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Super 9800 and 9600 Arm Systems. GE Health Medical Systems, Inc, Salt Lake City, UT 84116-2862
Terminated		 LLZK050400
Sep 25, 2007Cerner Corp
Cerner Millennium RadNet Auto Launch Study and Auto Launch Report software functionalities.
Terminated		 LLZK022881
Aug 7, 2007GE OEC Medical Systems, Inc
Cleaning probe included as an accessory to aspirators that are sterile packed single use disposable accessories to the GE InstaTrak 3500 Plus x-ray system. Probes are packaged and shipped together wit
Terminated		 LLZK960330
Mar 30, 2007GE OEC Medical Systems,Inc
InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body)
Terminated		 LLZK983529
Mar 28, 2007Siemens Medical Solutions, USA, Inc
Siemens syngo Dynamics 5.0 Workplace. Medical image report and archive system.
Terminated		 LLZK053133
Mar 13, 2007Stentor Inc A Phillips Medical Systems Co.
The iSight PACS (picture archiving and communications system) a software package used with general purpose computer hardware to acquire, store, distribute, process, and display images/associated data
Terminated		 LLZK042292
Jan 25, 2007GE Healthcare Integrated IT Solutions
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
Terminated		 LLZK043415
Oct 25, 2006Siemens Medical Solutions USA, Inc
Sienet Magic View 300, picture archiving and communications system. Model numbers 10014063 and 10014064
Terminated		 LLZK935694
Oct 25, 2006Siemens Medical Solutions USA, Inc
Sienet Sky, picture archiving and communications system. Model number 8463163
Terminated		 LLZK935694
Oct 25, 2006Siemens Medical Solutions USA, Inc
syngo Imaging, picture archiving and communications system. Model number 7502029
Terminated		 LLZK052461
Oct 25, 2006Siemens Medical Solutions USA, Inc
Sienet Cosmos V15C, picture archiving and communications system. Model number 10018969
Terminated		 LLZK042832
Oct 12, 2006AGFA Corp.
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
Terminated		 LLZK022292
Aug 3, 2006Philips Medical Systems North America Co. Phillips
Easy Vision Workstation Family (for the manipulation and displaying of x-ray images) with Multi Planar Reformat (MPR) Option
Terminated		 LLZK033088
Jul 27, 2006AGFA Corp.
IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images.
Terminated		 LLZK022292
Jul 13, 2006Siemens Medical Solutions, USA, Inc
KinetDx 4.0 Ultrasound Image Management System.
Terminated		 LLZK041029
May 19, 2006Philips Medical Systems (Cleveland) Inc
Extended Brilliance Workspace Imaging Workstation. An independent diagnostic viewing and processing workstation, for CT images.
Terminated		 LLZK012009
May 16, 2006Konica Minolta Medical Imaging USA, Inc.
REGIUS Image Manager (AKA REGIUS IM, RIM). Catalogue Number 5900554. Centralized CR Image Quality Control. Patient throughput optimization via offloaded processing from various CR readers. Technol
Terminated		 LLZK051523
May 9, 2006General Electric Med Systems LLC
Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2)
Terminated		 LLZK010336
Apr 7, 2006GE OEC Medical Systems,Inc
GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin Transmitter
Terminated		 LLZK022069
K983529 +1
Apr 6, 2006Sonosite, Inc.
SonoCalc IMT 3.0, a windows based software used in conjunction with images from high-resolution ultrasound systems (MicroMaxx, TITAN, and SonoSite180PLUS). This software generates a report with the p
Terminated		 LLZK030223
Mar 29, 2006Toshiba American Med Sys Inc
Toshiba America Medical Systems, Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film Device
Terminated		 LLZK961307
Mar 15, 2006Fujifilm Medical System USA, Inc.
Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS
Terminated		 LLZK051553
Jan 18, 2006Stentor Inc
''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3
Terminated		 LLZK042292
Jan 6, 2006AGFA Corp.
CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version 2.x)
Terminated		 LLZK010571
Oct 28, 2005Siemens Medical Solutions USA, Inc
Sienet Cosmos. Radiological Image Processing. Model number 10018971
Terminated		 LLZK042832
Aug 30, 2005GE Medical Systems Information Technologies
GE Healthcare Centricity Cardiology AI1000 Workstation version 4.2.6 and version 4.2.7.05
Terminated		 LLZK955519
Jun 16, 2005Philips Medical Systems North America Co. Phillips
View Forum 2003 software, SW 3.4L1
Terminated		 LLZK032096
May 11, 2005GE OEC Medical Systems,Inc
InstaTrak 3500 Plus Navigation and Visualization System
Terminated		 LLZK040050
K983529
May 11, 2005GE OEC Medical Systems,Inc
InstaTrak 3500 Navigation and Visualization System
Terminated		 LLZK960330
K983529
May 11, 2005GE OEC Medical Systems,Inc
ENTrak Plus Navigation and Visualization System
Terminated		 LLZK960330
May 11, 2005GE OEC Medical Systems,Inc
ENTrak Navigation and Visualization System
Terminated		 LLZK960330
Apr 8, 2005OEC Medical Systems, Inc
InstaTrak 3500 Plus Navigation and Visualization System
Terminated		 LLZK040050
Apr 8, 2005OEC Medical Systems, Inc
InstaTrak 3500 Navigation and Visualization System
Terminated		 LLZK003510
Apr 8, 2005OEC Medical Systems, Inc
InstaTrak 3000 Navigation and Visualization System
Terminated		 LLZK983529
Apr 8, 2005OEC Medical Systems, Inc
ENTrak Plus Navigation and Visualization System
Terminated		 LLZK960330
Apr 8, 2005OEC Medical Systems, Inc
ENTrak Navigation and Visualization System
Terminated		 LLZK960330
Mar 18, 2005Philips Medical Systems Sales & Service Region No. America
Xcelera R1.2 Cardiology image and information management solution software.
Terminated		 LLZK022788
Nov 3, 2004GE OEC Medical Systems,Inc
Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spine to provide a mounting point for a transmitter.
Terminated		 LLZK040050
Aug 4, 2004Philips Medical Systems Sales & Service Region No. America
ViewForum Review Station Part Numbers: 9896 507 71830, 9896 507 71831, and 9896 507 71832.
Terminated		 LLZNone listed

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