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)
Top companies in LLZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens AG Medical Solutions | 95 | 89 |
| GE Healthcare | 23 | 84 |
| Merge Healthcare Incorporated | 6 | 61 |
| Carestream Health, Inc. | 9 | 53 |
| Vital Images, Inc. | 34 | 10 |
| Agfa Corp. | 6 | 34 |
| Totoku Electric Co., Ltd. | 40 | 0 |
| Barco N.V. | 37 | 0 |
| Eizo Nanao Corporation | 34 | 0 |
| Ewoosoft Co., Ltd. | 29 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2013 | GE 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 |
LLZ | K043415 |
| Oct 30, 2013 | Ge 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 |
LLZ | K083018 |
| Oct 21, 2013 | AGFA Corp. IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS). Terminated |
LLZ | K071297 |
| Oct 21, 2013 | GE 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 |
LLZ | K112570 |
| Sep 30, 2013 | Mckesson 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 |
LLZ | K043146 |
| Sep 19, 2013 | GE 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 |
LLZ | K033400 |
| Sep 18, 2013 | GE Healthcare, LLC GE Healthcare, Advantage Workstation, READY View Application.
Image analysis software. Terminated |
LLZ | K110573 |
| Aug 27, 2013 | GE 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 |
LLZ | K103458 |
| Aug 15, 2013 | Siemens Medical Solutions USA, Inc Siemens syngo.plaza SW version VA20 with Mammography license.
image processing, radiological system Terminated |
LLZ | K093612 |
| Aug 1, 2013 | Siemens 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 |
LLZ | K102150 |
| May 9, 2013 | Novarad 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 |
LLZ | K063153 |
| May 6, 2013 | Merge Healthcare, Inc. RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K053281 |
| Apr 26, 2013 | Vital 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 |
LLZ | K032748 K121213 |
| Apr 23, 2013 | GE 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 |
LLZ | K051673 |
| Apr 18, 2013 | Vital 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 |
LLZ | K043333 K052632 |
| Apr 17, 2013 | GE 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 |
LLZ | K081985 |
| Apr 12, 2013 | Siemens 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 |
LLZ | None listed |
| Apr 8, 2013 | AGFA Corp. IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting.
Facilitates digital reports for catheterization, echocardiography, and congenital heart disease. Terminated |
LLZ | K050228 |
| Apr 8, 2013 | AGFA 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 |
LLZ | K050228 |
| Mar 27, 2013 | Vital 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 |
LLZ | K002519 K062154 |
| Mar 20, 2013 | Intio 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 |
LLZ | K113541 |
| Feb 18, 2013 | Ge 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 |
LLZ | K052618 |
| Dec 21, 2012 | NordicNeuroLab 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 |
LLZ | K092102 |
| Dec 19, 2012 | GE 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 |
LLZ | None listed |
| Dec 3, 2012 | Siemens Medical Solutions USA, Inc Siemens syngo.plaza Radiological Image Processing System
Usage: Radiological Image Processing System Terminated |
LLZ | K093612 |
| Nov 15, 2012 | GE 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 |
LLZ | K043415 |
| Nov 1, 2012 | Merge 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 |
LLZ | K092954 |
| Nov 1, 2012 | Vital 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 |
LLZ | K032748 K052632 |
| Oct 24, 2012 | GE 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 |
LLZ | K033400 |
| Oct 19, 2012 | GE 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 |
LLZ | K033400 |
| Oct 11, 2012 | Siemens Medical Solutions USA, Inc Siemens syngo.plaza radiological image processing system. Terminated |
LLZ | K093612 |
| Sep 26, 2012 | Imaging 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 |
LLZ | K090461 |
| Aug 28, 2012 | GE 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 |
LLZ | K960330 K981998 +4 |
| Aug 27, 2012 | Siemens Medical Solutions USA, Inc syngo.plaza, Model number 10592457.
Intended use: radiological image processing system. Terminated |
LLZ | K101666 |
| Aug 24, 2012 | Siemens Medical Solutions USA, Inc syngo Imaging XS.
Radiological image processing system. Terminated |
LLZ | K082430 |
| Aug 22, 2012 | AGFA Corp. AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device Terminated |
LLZ | K050228 |
| Aug 22, 2012 | GE 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 |
LLZ | K003510 |
| Aug 22, 2012 | Mckesson 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 |
LLZ | K043146 |
| Aug 17, 2012 | Siemens Medical Solutions, USA, Inc syngo Dynamics Version 9.5 Terminated |
LLZ | K102150 |
| Aug 13, 2012 | GE 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 |
LLZ | K020483 K052995 |
| Aug 10, 2012 | AGFA Corp. IMPAX Cardiovascular (CV) Reporting
Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF) Terminated |
LLZ | K050228 |
| Aug 8, 2012 | GE 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 |
LLZ | K994270 |
| Jul 26, 2012 | Siemens Medical Solutions USA, Inc Siemens syngo.plaza.
Radiological image processing system Terminated |
LLZ | K101666 |
| Jul 24, 2012 | AGFA 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 |
LLZ | K050228 |
| Jul 12, 2012 | GE 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 |
LLZ | K040050 |
| Jul 9, 2012 | GE 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 |
LLZ | K010336 K012313 |
| Apr 5, 2012 | Hologic, 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 |
LLZ | K103385 |
| Feb 29, 2012 | Siemens Medical Solutions USA, Inc Siemens syngo.plaza with software version VA20B_HF04
Product Usage:
Radiological image processing system Terminated |
LLZ | K093612 |
| Feb 20, 2012 | Siemens Medical Solutions USA, Inc Siemens syngo Imaging XS.
Radiological image processing system. Terminated |
LLZ | K082430 |
| Jan 20, 2012 | Siemens Medical Solutions USA, Inc Siemens syngo.plaza VA20A Server Farm setup integrated to a RIS, model number 10592457. Terminated |
LLZ | K101666 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.