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) |
|---|---|---|---|
| Jan 11, 2012 | Siemens Medical Solutions USA, Inc syngo.plaza
Image processing system Terminated |
LLZ | K093612 |
| Jan 11, 2012 | Siemens Medical Solutions USA, Inc syngo Imaging XS, all versions
Radiological image processing system Terminated |
LLZ | K082430 |
| Jan 11, 2012 | Siemens Medical Solutions USA, Inc syngo Imaging XS, versions VA70A and VA70B Client/Server Installations
Radiological image processing system Terminated |
LLZ | K082430 |
| Jan 11, 2012 | Vital Images, Inc. Vitrea (available in various configuration as Vitrea Enterprise Suite). Vitrea Enterprise Suite 1.2, Vitrea Enterprise Suite 1.3, Vitrea enterprise Suite 6.0 and Vitrea Enterprise Suite 6.1.
A medica Terminated |
LLZ | K061624 K071331 |
| Jan 11, 2012 | GE Healthcare, LLC GE Healthcare AW Server version 2.0 with release 2.0 - 4.0
A medical software system that allows multiple users to remotely access AW
applications from compatible computers on a network. Terminated |
LLZ | K081985 |
| Nov 23, 2011 | AGFA Corp. IMPAX CardioVascular (CV) Admin Tool
The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting Terminated |
LLZ | K050228 |
| Nov 18, 2011 | AGFA Corp. IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR)
The IMPAX Cardiovascular suite is a cardiovascular Information system providing image archiving and image display and modalit Terminated |
LLZ | K050228 |
| Nov 18, 2011 | AGFA Corp. IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2
The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image di Terminated |
LLZ | K050228 |
| Nov 10, 2011 | Philips Medical Systems Extended Brilliance Workstation-NM (EBW-NM)
with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test Period
A nuclear medicine image display and processing application suite that provi Terminated |
LLZ | K012009 K080961 |
| Oct 28, 2011 | Merge Healthcare, Inc. Fusion Workstation.; Indicated for the transmission and review of radiological images. Terminated |
LLZ | K983401 |
| Oct 19, 2011 | 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 |
| Oct 7, 2011 | Philips Healthcare Inc. MDC PACS - release R2.3 SP1 .
Phillips Healthcare
Andover, Massachusetts
A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portab Terminated |
LLZ | K072960 |
| Sep 27, 2011 | GE Healthcare, LLC ADVANTAGE WINDOWS (Workstation) WITH FUNCTOOL OPTION
GE Medical Systems, SCS.
A software module that provides supplemental information to those images extracted from CT and MR temporal datasets. Terminated |
LLZ | K960265 |
| Sep 14, 2011 | Philips Healthcare Inc. PCR Eleva Radiological Image Processing System with software R.1.2
Philips Healthcare, Inc.
A computed radiography image processing system. Terminated |
LLZ | K964124 |
| Sep 13, 2011 | Straumann Manufacturing Inc. Straumann coDiagnostiX, version 8.0, used to guide a clinician in the proper implant selection, oral placement and the proper selection of an oral drill.
Imaging processing System Terminated |
LLZ | K071636 |
| Aug 18, 2011 | Mckesson Information Solutions LLC Horizon Medical Imaging versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8.
Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit, st Terminated |
LLZ | K043146 |
| Aug 12, 2011 | GE Healthcare, LLC GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration, GE Healthcare 3000 North Grandview, Waukesha, WI 53188
Seno Advantage is a medical image review station that allows e Terminated |
LLZ | K033400 K052995 |
| Jul 8, 2011 | Siemens Medical Solutions, USA, Inc syngo Dynamics Picture Archiving Communication System
The software is a picture archiving and communication system intended for acceptance, transfer, display, storage, archive, and manipulation of di Terminated |
LLZ | None listed |
| Jun 28, 2011 | Eos Imaging Software versions
Eos software versions: 1.2.4, 1.2.5, 1.2.6,1.2.7,1.2.8, 1.2.9,1.2.10, .2.11,1.2.12, 1.2.13, 1.3.2,1.3.3, 1.3.4, 1.4.0, 1.4.1, 1.4.2.
sterEOS software versions: 1.2.3.3788, 1.2.4.428 Terminated |
LLZ | K071546 K101398 |
| Jun 10, 2011 | AGFA Corp. IMPAX CV (Cardio Vascular)
The IMPAX Cardiovascular suite is a cardiovascular information system, providing archiving, image display and modality/study specific structured reporting. Terminated |
LLZ | K050228 |
| May 25, 2011 | Siemens Medical Solutions, USA, Inc syngo Dynamics version 9.0, Siemens Medical Solutions, USA, Inc., Ann Arbor, MI.
The syngo Dynamics is a picture archiving and communications system intended for acceptance, transfer, display, storag Terminated |
LLZ | K102150 |
| May 24, 2011 | AGFA Corp. IMPAX 6.5 Client Software.
IMPAX 6.5 combines the traditional activities of RIS informatics management with PACS image management to provide a powerful platform for imaging-based planning, interpreta Terminated |
LLZ | K022292 |
| May 13, 2011 | Digisonics, Inc Digisonics, Digiview and ERS software releases 3.6.44, 3.6.4.6, and 3.6.5, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098, Tel: (800) 940-3240, Fax: (713) 529-7999
Software used to make on-scr Terminated |
LLZ | K970402 |
| May 10, 2011 | Digisonics, Inc DigiView software release 3.4.4.4 through 3.5.5.2. , 2008 Digisonics, Inc, 800-940-3240.
Digiview is a digital image management and reporting system with an associated clinical database. It provides Terminated |
LLZ | K970402 |
| May 10, 2011 | Digisonics, Inc Digisonics, DigiView and ERS software release 3.6.4.4 through 3.6.5.2+, 2008 Digisonics, Inc., 3701 Kirby Drive, Houston TX 77098, 800-940-3240.
DigiView is a digital image management and reporting Terminated |
LLZ | K970402 |
| Apr 29, 2011 | Digisonics, Inc Doctors Review System, OB-Windows/OB-View software release numbers 4.1 through 4.1.3, Digisonics, Inc., 3701 Kirby Drive, Houston, TX 77098
OB-Windows provides professional reporting and analysis of Terminated |
LLZ | K970402 |
| Apr 11, 2011 | GE OEC Medical Systems, Inc Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116.
Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500 Terminated |
LLZ | K040050 |
| Apr 11, 2011 | GE OEC Medical Systems, Inc Transmitter Sensor Cables, Part Numbers: 1002008, 1004587, 1007914-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116.
Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500, IT25 Terminated |
LLZ | K040050 |
| Mar 16, 2011 | AGFA Corp. IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8 Terminated |
LLZ | K050228 |
| Mar 7, 2011 | Straumann Manufacturing Inc. Straumann coDiagnostiX, dental implant planning system.
Software Version 7.0 including updates 7.0.2 and 7.0.2.10 Terminated |
LLZ | K071636 |
| Feb 25, 2011 | AGFA Corp. IMPAX CV Results Manager/Results Manager Administration Tool
The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-speci Terminated |
LLZ | K050228 |
| Feb 24, 2011 | AGFA Corp. Cardiovascular Review Station
The IMPAX Cardiovascular suite is a cardiovascular information system, providing image archiving, image display and modality/study specific structured reporting. Terminated |
LLZ | K050228 |
| Feb 15, 2011 | GE Healthcare, LLC Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0
The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, includ Terminated |
LLZ | K024137 K051673 +1 |
| Feb 4, 2011 | Philips Medical Systems North America Co. Phillips PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Philips Electronics... www.medical.philips.com... Philips Medical Systems Nederland B.V".
Provides on Terminated |
LLZ | K964124 |
| Feb 2, 2011 | Vital Images, Inc. Vital Connect 4.0 & 4.1, radiological image processing software
A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired fro Terminated |
LLZ | K062154 K071362 |
| Dec 29, 2010 | AGFA Corp. Mammography Keypad
Radiologists and Technologist apply hotkeys from a keyboard for ease of use in their clinical and diagnostic activities. The Agfa Mammography Keypad allows users the ability to appl Terminated |
LLZ | K081976 |
| Dec 21, 2010 | Vital Images, Inc. Vital, Vitrea fX and Vitrea Enterprise Suite fX
Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1
Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3
The Vitrea 4D CT Brain Perfusion option is intende Terminated |
LLZ | K072821 |
| Dec 3, 2010 | GE Healthcare, LLC XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND REVIEW WORKSTATION
The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, incl Terminated |
LLZ | K024137 K051673 |
| Nov 26, 2010 | GE Healthcare, LLC GE Healthcare IDI Mammo Workstation Terminated |
LLZ | None listed |
| Nov 26, 2010 | GE Healthcare, LLC GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Terminated |
LLZ | K033400 |
| Nov 18, 2010 | Philips Medical Systems North America Co. Phillips Philips EasyVision MM workstation with software R10.2 and R11.1
The EasyVision MM Workstation is intended for the manipulation and display of medical images, including mammograms. It can show images f Terminated |
LLZ | K051315 K063093 |
| Jul 29, 2010 | AGFA Corp. IMPAX CV Results Manager/Results Manager Administration Tool Terminated |
LLZ | K050228 |
| Jul 13, 2010 | Medtronic Navigation, Inc. O-Arm Imaging System
The O-Arm imaging system is a mobile X-Ray system designed for medical applications in surgical theaters, focusing on 3D imaging but also offering 2D fluoroscopic Imaging. Terminated |
LLZ | K050996 K060344 |
| Jun 24, 2010 | Siemens Medical Solutions USA, Inc Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS. Terminated |
LLZ | K082430 |
| Jun 11, 2010 | AGFA Corp. DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601.
Intended to display mammographic images. Terminated |
LLZ | None listed |
| Jun 2, 2010 | Ge Healthcare, Llc GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02
Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interch Terminated |
LLZ | K033400 |
| May 28, 2010 | Mckesson Medical Immaging Voiceware clip software update to certain Horizon Medical Imaging Systems. McKesson Medical Imaging Company. Richmond, Canada V6X 3G5.
Intended to receive, transmit, store, retrieve, display, print Terminated |
LLZ | K043146 |
| May 13, 2010 | Vital Images, Inc. Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon. Terminated |
LLZ | K091498 |
| Apr 20, 2010 | Siemens Medical Solutions USA, Inc Syngo Imaging XS model number 10496279
The intended use: image processing radiological Terminated |
LLZ | K082430 |
| Apr 16, 2010 | Ge Healthcare It GE Centricity Web Diagnostic (WebDX) software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010.
Device that receives, stores and communicates medical images and data from various imaging Terminated |
LLZ | K083018 |
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