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

DateFirm and productCodeLinked 510(k)
Apr 16, 2010Ge Healthcare It
GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. Device that receives, stores and communicates medical images and data from various imaging sources.
Terminated
LLZK082318
Apr 15, 2010Ge Healthcare It
GE Centricity Web Diagnostic 1.0(WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Intended use:The Centricity PACS-IW is used to receive medical images (including ma
Terminated
LLZK083018
Apr 15, 2010Ge Healthcare It
GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use:The Centricity PACS-IW is used to receive medical images (including mammograms) and data
Terminated
LLZK082318
Nov 24, 2009GE Healthcare Integrated IT Solutions
GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS is used to receive, stor
Terminated
LLZK043415
Nov 18, 2009AGFA Corp.
AGFA IMPAX HeartStation ECG Management System.
Terminated
LLZK050858
Nov 16, 2009Siemens Medical Solutions USA, Inc
Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression
Terminated
LLZK082430
Nov 16, 2009Siemens Medical Solutions USA, Inc
Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression.
Terminated
LLZK082430
Nov 10, 2009Siemens Medical Solutions USA, Inc
Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license
Terminated
LLZK082430
Sep 22, 2009IMTEC IMAGING L.L.C.
ILUMAVision Software, version 2.1.0 Picture Archiving and Communication system Product used as a tool for the pre-surgical planning of the placement of dental implants and pre-surgical fabrication of
Terminated
LLZK081347
Sep 8, 2009AGFA Corp.
Agfa Impax R6.3 DB Server. Impax Systems are Picture Archiving and Communication systems (PACs). PAC systems are used in the acceptance, transfer, display, storage and digital processing of medical
Terminated
LLZK022292
Sep 2, 2009AGFA Corp.
NX 2008 Central Monitoring System (CMS). Product code: E2FB6 Agfa's Computed Radiography Systems with NX Workstations are intended for use in providing diagnostic quality images to aid the physicia
Terminated
LLZK090672
Aug 27, 2009Intelerad Medical Systems Inc.
IntelePACS Picture Archiving Communications System InteleViewer module, Model #3.X.X.
Terminated
LLZK070080
Aug 27, 2009Intelerad Medical Systems Inc.
IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X.
Terminated
LLZK070080
Jul 13, 2009GE Healthcare Integrated IT Solutions
GE Centricity PACS RA1000 Workstation software (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS (Picture Archiving and Communication
Terminated
LLZK043415
Jul 9, 2009Xoran Technologies, Inc.
XoranConnect, software version 4.1.0.6, Xoran Technologies, Ann Arbor, MI. A web-based software which provides online multi-planar image viewing, offsite data storage, administrative reporting tools
Terminated
LLZK073306
Jul 7, 2009Siemens Medical Solutions USA, Inc
syngo Imaging Version V31 Picture Archiving and Communication System, model number 10014063.
Terminated
LLZK081734
Jul 1, 2009GE Healthcare Integrated IT Solutions
GE Centricity PACS (Picture Archiving and Communication System) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS is used to receive, store, distribute, displ
Terminated
LLZK043415
Apr 28, 2009Siemens Medical Solutions USA, Inc
syngo Imaging model number 10014063. Affected systems are V30A or earlier with an NFS connected archive and V30A systems where image data was stored to LTS using software version older than V30A. Pic
Terminated
LLZNone listed
Apr 28, 2009Siemens Medical Solutions USA, Inc
syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063
Terminated
LLZK071114
Feb 3, 2009GE Healthcare Integrated IT Solutions
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS (Picture Archiving and Communication System) Wor
Terminated
LLZK043415
Feb 3, 2009GE Healthcare Integrated IT Solutions
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS (Picture Archiving and Communication System) Wo
Terminated
LLZK043415
Feb 3, 2009AGFA Corp.
IMPAX Cardiovascular Polling Procedure version 1.00.09, used in IMPAX 6.2.1 and 6.3.1.; Catalog numbers: E18R4000, L5NQJ000, L57OP000, LBCDB000, and E2ZCK000. IMPAX Cardiovascular is a picture archiv
Terminated
LLZK022292
K050228
Jan 30, 2009Philips Healthcare Informatics, Inc.
iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3, manufactured by Philips Healthcare Informatics, Foster City, CA. Device is an image management sys
Terminated
LLZK063267
Jan 27, 2009GE Healthcare Integrated IT Solutions
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS Workstation is intended for use as a primary d
Terminated
LLZK043415
Jan 23, 2009GE Healthcare Integrated IT Solutions
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS Workstation is intended for use as a primary dia
Terminated
LLZK043415
Jan 8, 2009Siemens Medical Solutions USA, Inc
CT syngo Dual Energy Viewer on the syngo Multimodality Work Place (MMWP) and on the CT workplace, Model number 10094833. Picture Archiving and Communications System.
Terminated
LLZK052775
Jan 2, 2009Siemens Medical Solutions, USA, Inc
Siemens syngo Dynamics Workplace, version 6.0, Siemens Medical Solutions, Ann Arbor, MI; 10090334. Intended for acceptance, transfer, display, storage, archive and manipulation of digital medical ima
Terminated
LLZK070322
Jan 2, 2009Siemens Medical Solutions, USA, Inc
Siemens syngo Dynamics Workplace, version 5.0, Siemens Medical Solutions, Ann Arbor, MI; 10090310. Intended for acceptance, transfer, display, storage, archive and manipulation of digital medical ima
Terminated
LLZK053133
Jan 2, 2009Siemens Medical Solutions, USA, Inc
Siemens KinetDx 4.2 Workplace, Siemens Medical Solutions, Ann Arbor, MI; 10090235. Indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or
Terminated
LLZK040896
Dec 13, 2008GE Healthcare Integrated IT Solutions
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity" PACS Workstation is intended for use as a primary d
Terminated
LLZK043415
Dec 3, 2008Siemens Medical Solutions USA, Inc
syngo MultiModality WorkPlace (MM WP). Software product(Model Number 10140720). The product is intended for use in picture archiving and communications system.
Terminated
LLZK010938
Oct 28, 2008Philips Healthcare Informatics, Inc.
iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is an image management system (software package) used with general purpose computing hardwar
Terminated
LLZK042292
K063267
Oct 15, 2008Siemens Medical Solutions USA, Inc
Syngo Imaging with versions VB20B, VB20D, VB20F, VB20G, VB25B, VB30A, VB30A_SP1, and VB30A_SP2.
Terminated
LLZK052461
K071114
Sep 29, 2008Siemens Medical Solutions, USA, Inc
Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system
Terminated
LLZK070322
Sep 20, 2008GE Healthcare
Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. Model Numbers 5183652 & 5142878.
Terminated
LLZK041521
Sep 18, 2008Philips Healthcare Informatics, Inc.
Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x The system is a software package used with general purpose computing hardware to acquire, store,
Terminated
LLZK042292
Sep 16, 2008GE Healthcare Integrated IT Solutions
GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic image analysis; GE Healthcare Integrated IT Solutions, Barrington, IL 60010
Terminated
LLZK061372
Sep 16, 2008Philips Medical Systems North America Co. Phillips
EasyVision RAD - Radiological Image Processor, software versions: SW R4 2V2L2, SW R4 2V2L3, SW R4 2V2L4, SW R4 2V2L5, SW R4 2V2L6, and SW R4 2V2L7. The EasyVision RAD consists of a computer with digi
Terminated
LLZK920950
K963980
Sep 11, 2008AGFA Corp.
WEB1000 Versions 3.1, 4.1 and 5.1, Picture Archiving and Communications systems (PACs), used in the acceptance, transfer, display, storage and digital processing of medical images.
Terminated
LLZK022292
K040555 +3
Sep 11, 2008AGFA Corp.
IMPAX 6.2.1 System, Picture Archiving and Communications system (PAC), used in the acceptance, transfer, display, storage and digital processing of medical images.
Terminated
LLZK040555
K050751
Sep 11, 2008AGFA Corp.
IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2, IMPAX 6.0, IMPAX 6.2; Picture Archiving and Communications systems (PACs), used in the acceptance, transfer, display, storage and digital pr
Terminated
LLZK022292
K040555 +3
Sep 4, 2008AGFA Corp.
Impax 6.x Clients including: 6.3 all versions below 6.3.1 SU5, 6.2 all versions below 6.2.1 SU14 and 6.0 all versions. The Impax Systems are Picture Archiving and Communications system (PACs). PAC s
Terminated
LLZK022292
Sep 3, 2008MIMvista Corp
MIM 4.0 and MIM 4.1 is a software package designed for use in diagnostic imaging. It is a stand alone software package which operates on Windows 2000/XP.
Terminated
LLZK060816
K071964
Sep 2, 2008GE Healthcare Integrated IT Solutions
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010
Terminated
LLZK043415
Sep 2, 2008GE Healthcare Integrated IT Solutions
GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation; for diagnostic image analysis; GE Healthcare Integrated IT Solutions, Barrington, IL 60010
Terminated
LLZK061372
Aug 24, 2008Siemens Medical Solutions USA, Inc
Syn go Imaging XS is a picture archiving and communication system intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital
Terminated
LLZK071114
Aug 16, 2008Philips Healthcare Informatics, Inc.
Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0 - Radiology Image management system.
Terminated
LLZK063267
Aug 16, 2008Philips Healthcare Informatics, Inc.
Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 3.6.28.0 - Radiology Image management system.
Terminated
LLZK042292
Jul 2, 2008AGFA Corp.
Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D software; and Impax 5.0 and Impax 5.2 PACs with integrated MediCAD software. The softwares ar
Terminated
LLZK022292
Jun 27, 2008AGFA Corp.
Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891
Terminated
LLZK050228

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