ClearanceBrief
Panels › Radiology › Product code LLZ · Class 2

System, Image Processing, Radiological

Regulation 892.2050

48510(k)s in 12 months (2,295 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)
Oct 30, 2013GE Healthcare It
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologis
Terminated
LLZK043415
Oct 30, 2013Ge Healthcare It
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, comm
Terminated
LLZK083018
Oct 21, 2013AGFA Corp.
IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
Terminated
LLZK071297
Oct 21, 2013GE Healthcare It
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It will be sold as a software only device to operate on general purpose computing
Terminated
LLZK112570
Sep 30, 2013Mckesson Information Solutions LLC
McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit,
Terminated
LLZK043146
Sep 19, 2013GE Healthcare, LLC
GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. Seno Advantage is
Terminated
LLZK033400
Sep 18, 2013GE Healthcare, LLC
GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
Terminated
LLZK110573
Aug 27, 2013GE Healthcare, LLC
GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electron
Terminated
LLZK103458
Aug 15, 2013Siemens Medical Solutions USA, Inc
Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system
Terminated
LLZK093612
Aug 1, 2013Siemens Medical Solutions USA, Inc
syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical ima
Terminated
LLZK102150
May 9, 2013Novarad Corporation
NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
Terminated
LLZK063153
May 6, 2013Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Terminated
LLZK053281
Apr 26, 2013Vital Images, Inc.
Vitrea CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to e
Terminated
LLZK032748
K121213
Apr 23, 2013GE Healthcare, LLC
GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including
Terminated
LLZK051673
Apr 18, 2013Vital Images, Inc.
Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdv
Terminated
LLZK043333
K052632
Apr 17, 2013GE Healthcare, LLC
GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system all
Terminated
LLZK081985
Apr 12, 2013Siemens Medical Solutions USA, Inc
Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated mo
Terminated
LLZNone listed
Apr 8, 2013AGFA Corp.
IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease.
Terminated
LLZK050228
Apr 8, 2013AGFA Corp.
IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric ech
Terminated
LLZK050228
Mar 27, 2013Vital Images, Inc.
Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows t
Terminated
LLZK002519
K062154
Mar 20, 2013Intio Inc
INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, i
Terminated
LLZK113541
Feb 18, 2013Ge Healthcare It
Imagecast PACS with Centricity RIS-IC versions prior to 10.6 Update Package 18 Product Usage: is an image management system intended to be used by trained professionals, including but not limited to
Terminated
LLZK052618
Dec 21, 2012NordicNeuroLab AS
nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software ru
Terminated
LLZK092102
Dec 19, 2012GE Healthcare, LLC
Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more of these applications is installed: " VesselIQ Xpre
Terminated
LLZNone listed
Dec 3, 2012Siemens Medical Solutions USA, Inc
Siemens syngo.plaza Radiological Image Processing System Usage: Radiological Image Processing System
Terminated
LLZK093612
Nov 15, 2012GE Healthcare It
GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcar
Terminated
LLZK043415
Nov 1, 2012Merge Healthcare, Inc.
CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream als
Terminated
LLZK092954
Nov 1, 2012Vital Images, Inc.
Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6
Terminated
LLZK032748
K052632
Oct 24, 2012GE Healthcare, LLC
GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-m
Terminated
LLZK033400
Oct 19, 2012GE Healthcare, LLC
GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection,
Terminated
LLZK033400
Oct 11, 2012Siemens Medical Solutions USA, Inc
Siemens syngo.plaza radiological image processing system.
Terminated
LLZK093612
Sep 26, 2012Imaging Sciences International, LLC
DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Terminated
LLZK090461
Aug 28, 2012GE OEC Medical Systems, Inc
OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems a
Terminated
LLZK960330
K981998 +4
Aug 27, 2012Siemens Medical Solutions USA, Inc
syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
Terminated
LLZK101666
Aug 24, 2012Siemens Medical Solutions USA, Inc
syngo Imaging XS. Radiological image processing system.
Terminated
LLZK082430
Aug 22, 2012AGFA Corp.
AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
Terminated
LLZK050228
Aug 22, 2012GE OEC Medical Systems, Inc
OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical con
Terminated
LLZK003510
Aug 22, 2012Mckesson Medical Imaging Group
Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print
Terminated
LLZK043146
Aug 17, 2012Siemens Medical Solutions, USA, Inc
syngo Dynamics Version 9.5
Terminated
LLZK102150
Aug 13, 2012GE Healthcare, LLC
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 Workstation 4.4 with Vol
Terminated
LLZK020483
K052995
Aug 10, 2012AGFA Corp.
IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)
Terminated
LLZK050228
Aug 8, 2012GE OEC Medical Systems, Inc
Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benef
Terminated
LLZK994270
Jul 26, 2012Siemens Medical Solutions USA, Inc
Siemens syngo.plaza. Radiological image processing system
Terminated
LLZK101666
Jul 24, 2012AGFA Corp.
IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, p
Terminated
LLZK050228
Jul 12, 2012GE OEC Medical Systems, Inc
InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during op
Terminated
LLZK040050
Jul 9, 2012GE Healthcare, LLC
GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides
Terminated
LLZK010336
K012313
Apr 5, 2012Hologic, Inc.
Hologics SecurView DX workstation, software version 7.3.0 intended for viewing mammography images and other imaging modalities. SecurView DX is intended for selection, display, manipulation, filing
Terminated
LLZK103385
Feb 29, 2012Siemens Medical Solutions USA, Inc
Siemens syngo.plaza with software version VA20B_HF04 Product Usage: Radiological image processing system
Terminated
LLZK093612
Feb 20, 2012Siemens Medical Solutions USA, Inc
Siemens syngo Imaging XS. Radiological image processing system.
Terminated
LLZK082430
Jan 20, 2012Siemens Medical Solutions USA, Inc
Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457.
Terminated
LLZK101666

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