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)
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) |
|---|---|---|---|
| Apr 16, 2010 | Ge 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 |
LLZ | K082318 |
| Apr 15, 2010 | Ge 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 |
LLZ | K083018 |
| Apr 15, 2010 | Ge 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 |
LLZ | K082318 |
| Nov 24, 2009 | GE 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 |
LLZ | K043415 |
| Nov 18, 2009 | AGFA Corp. AGFA IMPAX HeartStation ECG Management System. Terminated |
LLZ | K050858 |
| Nov 16, 2009 | Siemens Medical Solutions USA, Inc Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression Terminated |
LLZ | K082430 |
| Nov 16, 2009 | Siemens Medical Solutions USA, Inc Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression. Terminated |
LLZ | K082430 |
| Nov 10, 2009 | Siemens Medical Solutions USA, Inc Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license Terminated |
LLZ | K082430 |
| Sep 22, 2009 | IMTEC 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 |
LLZ | K081347 |
| Sep 8, 2009 | AGFA 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 |
LLZ | K022292 |
| Sep 2, 2009 | AGFA 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 |
LLZ | K090672 |
| Aug 27, 2009 | Intelerad Medical Systems Inc. IntelePACS Picture Archiving Communications System InteleViewer module, Model #3.X.X. Terminated |
LLZ | K070080 |
| Aug 27, 2009 | Intelerad Medical Systems Inc. IntelePACS Picture Archiving Communications System InteleViewer Workstation Model #3.X.X. Terminated |
LLZ | K070080 |
| Jul 13, 2009 | GE 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 |
LLZ | K043415 |
| Jul 9, 2009 | Xoran 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 |
LLZ | K073306 |
| Jul 7, 2009 | Siemens Medical Solutions USA, Inc syngo Imaging Version V31 Picture Archiving and Communication System, model number 10014063. Terminated |
LLZ | K081734 |
| Jul 1, 2009 | GE 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 |
LLZ | K043415 |
| Apr 28, 2009 | Siemens 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 |
LLZ | None listed |
| Apr 28, 2009 | Siemens Medical Solutions USA, Inc syngo Imaging, picture archiving and communications system (PACS), Model number 10 014 063 Terminated |
LLZ | K071114 |
| Feb 3, 2009 | GE 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 |
LLZ | K043415 |
| Feb 3, 2009 | GE 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 |
LLZ | K043415 |
| Feb 3, 2009 | AGFA 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 |
LLZ | K022292 K050228 |
| Jan 30, 2009 | Philips 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 |
LLZ | K063267 |
| Jan 27, 2009 | GE 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 |
LLZ | K043415 |
| Jan 23, 2009 | GE 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 |
LLZ | K043415 |
| Jan 8, 2009 | Siemens 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 |
LLZ | K052775 |
| Jan 2, 2009 | Siemens 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 |
LLZ | K070322 |
| Jan 2, 2009 | Siemens 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 |
LLZ | K053133 |
| Jan 2, 2009 | Siemens 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 |
LLZ | K040896 |
| Dec 13, 2008 | GE 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 |
LLZ | K043415 |
| Dec 3, 2008 | Siemens 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 |
LLZ | K010938 |
| Oct 28, 2008 | Philips 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 |
LLZ | K042292 K063267 |
| Oct 15, 2008 | Siemens Medical Solutions USA, Inc Syngo Imaging with versions VB20B, VB20D, VB20F, VB20G, VB25B, VB30A, VB30A_SP1, and VB30A_SP2. Terminated |
LLZ | K052461 K071114 |
| Sep 29, 2008 | Siemens Medical Solutions, USA, Inc Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system Terminated |
LLZ | K070322 |
| Sep 20, 2008 | GE Healthcare Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. Model Numbers 5183652 & 5142878. Terminated |
LLZ | K041521 |
| Sep 18, 2008 | Philips 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 |
LLZ | K042292 |
| Sep 16, 2008 | GE 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 |
LLZ | K061372 |
| Sep 16, 2008 | Philips 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 |
LLZ | K920950 K963980 |
| Sep 11, 2008 | AGFA 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 |
LLZ | K022292 K040555 +3 |
| Sep 11, 2008 | AGFA 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 |
LLZ | K040555 K050751 |
| Sep 11, 2008 | AGFA 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 |
LLZ | K022292 K040555 +3 |
| Sep 4, 2008 | AGFA 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 |
LLZ | K022292 |
| Sep 3, 2008 | MIMvista 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 |
LLZ | K060816 K071964 |
| Sep 2, 2008 | GE Healthcare Integrated IT Solutions GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integrated IT Solutions, Barrington, IL 60010 Terminated |
LLZ | K043415 |
| Sep 2, 2008 | GE 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 |
LLZ | K061372 |
| Aug 24, 2008 | Siemens 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 |
LLZ | K071114 |
| Aug 16, 2008 | Philips Healthcare Informatics, Inc. Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0 - Radiology Image management system. Terminated |
LLZ | K063267 |
| Aug 16, 2008 | Philips Healthcare Informatics, Inc. Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 3.6.28.0 - Radiology Image management system. Terminated |
LLZ | K042292 |
| Jul 2, 2008 | AGFA 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 |
LLZ | K022292 |
| Jun 27, 2008 | AGFA Corp. Agfa Heartlab Cardiovascular Results Management Product: Versions 2.03 and 2.04. Heartlab, Inc., Westerly, Rhode Island 02891 Terminated |
LLZ | K050228 |
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