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)
Jan 11, 2012Siemens Medical Solutions USA, Inc
syngo.plaza Image processing system
Terminated
LLZK093612
Jan 11, 2012Siemens Medical Solutions USA, Inc
syngo Imaging XS, all versions Radiological image processing system
Terminated
LLZK082430
Jan 11, 2012Siemens Medical Solutions USA, Inc
syngo Imaging XS, versions VA70A and VA70B Client/Server Installations Radiological image processing system
Terminated
LLZK082430
Jan 11, 2012Vital 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
LLZK061624
K071331
Jan 11, 2012GE 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
LLZK081985
Nov 23, 2011AGFA 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
LLZK050228
Nov 18, 2011AGFA 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
LLZK050228
Nov 18, 2011AGFA 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
LLZK050228
Nov 10, 2011Philips 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
LLZK012009
K080961
Oct 28, 2011Merge Healthcare, Inc.
Fusion Workstation.; Indicated for the transmission and review of radiological images.
Terminated
LLZK983401
Oct 19, 2011Merge 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
Oct 7, 2011Philips 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
LLZK072960
Sep 27, 2011GE 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
LLZK960265
Sep 14, 2011Philips Healthcare Inc.
PCR Eleva Radiological Image Processing System with software R.1.2 Philips Healthcare, Inc. A computed radiography image processing system.
Terminated
LLZK964124
Sep 13, 2011Straumann 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
LLZK071636
Aug 18, 2011Mckesson 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
LLZK043146
Aug 12, 2011GE 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
LLZK033400
K052995
Jul 8, 2011Siemens 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
LLZNone listed
Jun 28, 2011Eos 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
LLZK071546
K101398
Jun 10, 2011AGFA 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
LLZK050228
May 25, 2011Siemens 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
LLZK102150
May 24, 2011AGFA 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
LLZK022292
May 13, 2011Digisonics, 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
LLZK970402
May 10, 2011Digisonics, 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
LLZK970402
May 10, 2011Digisonics, 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
LLZK970402
Apr 29, 2011Digisonics, 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
LLZK970402
Apr 11, 2011GE 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
LLZK040050
Apr 11, 2011GE 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
LLZK040050
Mar 16, 2011AGFA Corp.
IMPAX Remote Cardiology Review Station, a cardiovascular information system. Model Number CV7.8
Terminated
LLZK050228
Mar 7, 2011Straumann Manufacturing Inc.
Straumann coDiagnostiX, dental implant planning system. Software Version 7.0 including updates 7.0.2 and 7.0.2.10
Terminated
LLZK071636
Feb 25, 2011AGFA 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
LLZK050228
Feb 24, 2011AGFA 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
LLZK050228
Feb 15, 2011GE 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
LLZK024137
K051673 +1
Feb 4, 2011Philips 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
LLZK964124
Feb 2, 2011Vital 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
LLZK062154
K071362
Dec 29, 2010AGFA 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
LLZK081976
Dec 21, 2010Vital 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
LLZK072821
Dec 3, 2010GE 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
LLZK024137
K051673
Nov 26, 2010GE Healthcare, LLC
GE Healthcare IDI Mammo Workstation
Terminated
LLZNone listed
Nov 26, 2010GE Healthcare, LLC
GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1
Terminated
LLZK033400
Nov 18, 2010Philips 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
LLZK051315
K063093
Jul 29, 2010AGFA Corp.
IMPAX CV Results Manager/Results Manager Administration Tool
Terminated
LLZK050228
Jul 13, 2010Medtronic 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
LLZK050996
K060344
Jun 24, 2010Siemens Medical Solutions USA, Inc
Syngo Imaging Version Lines VB20, VB30, VB35 in combination with a RIS.
Terminated
LLZK082430
Jun 11, 2010AGFA Corp.
DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display mammographic images.
Terminated
LLZNone listed
Jun 2, 2010Ge 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
LLZK033400
May 28, 2010Mckesson 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
LLZK043146
May 13, 2010Vital Images, Inc.
Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the licensing of CT lung or CT Colon.
Terminated
LLZK091498
Apr 20, 2010Siemens Medical Solutions USA, Inc
Syngo Imaging XS model number 10496279 The intended use: image processing radiological
Terminated
LLZK082430
Apr 16, 2010Ge 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
LLZK083018

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