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)
Aug 27, 2015GE Healthcare
Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities rela
Terminated
LLZNone listed
Aug 27, 2015GE Healthcare
Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities
Terminated
LLZNone listed
Jul 23, 2015Merge Healthcare, Inc.
Merge Unity Z3D software. Merge Unity PACS (formerly DR Systems PACS) is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, an
Terminated
LLZK041935
Jul 13, 2015AGFA Healthcare Corp.
IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, rev
Terminated
LLZNone listed
Jul 3, 2015NordicNeuroLab AS
nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standa
Terminated
LLZK082441
Jul 2, 2015Siemens Medical Solutions USA, Inc
SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital
Terminated
LLZK071114
K081734
Jun 15, 2015Philips Ultrasound, Inc.
Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and rep
Terminated
LLZK140808
Jun 3, 2015Siemens Medical Solutions USA, Inc
Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
Terminated
LLZK092519
K123375
Mar 30, 2015Siemens Medical Solutions USA, Inc
Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physic
Terminated
LLZK093612
K132532 +1
Mar 4, 2015iCAD, Inc.
DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
Terminated
LLZK090223
Feb 26, 2015GE Healthcare
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
Feb 9, 2015TeraRecon, Inc.
Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. A full
Terminated
LLZK121916
Jan 28, 2015Siemens Medical Solutions USA, Inc
Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It suppo
Terminated
LLZK093612
K132532 +1
Dec 17, 2014Carestream Health, Inc.
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Terminated
LLZK020635
K923554
Dec 16, 2014Philips Ultrasound, Inc.
Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: Q-Station, Catalog number: 795088, and Part Number: 989605382391. Intended to manage, view, analyze
Terminated
LLZK140808
Dec 16, 2014Philips Ultrasound, Inc.
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. ************************************************
Terminated
LLZK132165
Dec 15, 2014NordicNeuroLab AS
nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a st
Terminated
LLZK123306
Dec 15, 2014Siemens Medical Solutions USA, Inc
Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, di
Terminated
LLZK082430
K093612 +1
Oct 15, 2014Merge Healthcare, Inc.
eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that
Terminated
LLZK012211
K020995
Sep 17, 2014NordicNeuroLab AS
nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
Terminated
LLZK133910
Sep 12, 2014NordicNeuroLab AS
nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians.
Terminated
LLZK082441
Aug 19, 2014Intelerad Medical Systems
IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems,
Terminated
LLZK083520
Aug 16, 2014Philips Healthcare Informatics, Inc.
Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Terminated
LLZK111804
Jul 30, 2014Brainlab AG
Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06.
Terminated
LLZK093117
Jul 28, 2014Mckesson Medical Immaging
Horizon Medical Imaging It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display print and process digital medical images, digital
Terminated
LLZK043146
Jul 23, 2014Siemens Medical Solutions USA, Inc
Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store an
Terminated
LLZK082430
Jul 23, 2014Philips Ultrasound, Inc.
QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products
Terminated
LLZK152165
Jul 23, 2014Philips Ultrasound, Inc.
QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products.
Terminated
LLZK152165
Jun 6, 2014Mckesson Medical Immaging
Horizon Medical Imaging Horizon Medical Imaging is a medical image and information management application that is intended to receive transmit, store, retrieve, display, print and process digital med
Terminated
LLZK043146
May 28, 2014GE Healthcare
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professional, including radiologists, physicians, technologist
Terminated
LLZK043415
May 27, 2014AGFA Corp.
IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) Service IMPAX. For the creation of digital structured reports for cardiovascular diagnostic
Terminated
LLZK050228
May 16, 2014Siemens Medical Solutions USA, Inc
syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images.
Terminated
LLZK033831
K042832 +1
May 13, 2014Mckesson Medical Immaging
McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, d
Terminated
LLZK043146
May 13, 2014Siemens Medical Solutions USA, Inc
Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quan
Terminated
LLZK023772
K102150
Apr 25, 2014GE Healthcare, LLC
GE Healthcare, CardiacVX [CardiacVX (1.1.0 Ext. d) and CardiacVX Flow (1.1.0 Ext. d) analysis software running on Advantage Workstation]. Model #'s 5434389-2 and 5434384-2. The GE Cardiac VX for MRI
Terminated
LLZK121762
Apr 24, 2014Philips Medical Systems, Inc.
Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital medi
Terminated
LLZK072960
Mar 25, 2014Velocity Medical Solutions, LLC
DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison o
Terminated
LLZK081076
Mar 18, 2014Siemens Medical Solutions USA, Inc
syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
Terminated
LLZK023772
K102150
Feb 12, 2014Mckesson Information Solutions LLC
Horizon Medical Imaging, Picture Archive Communication System (PACS).
Terminated
LLZK043146
Feb 3, 2014AGFA Corp.
IMPAX RIS QDOC 5.8
Terminated
LLZK111945
Jan 15, 2014Ge Healthcare It
Imagecast PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purp
Terminated
LLZK052618
Jan 14, 2014GE Healthcare It
Merge Mammo is a multi-modality, vendor-neutral digital mammography workstation that enables imaging centers to use a single workstation to display and read images from different vendors and different
Terminated
LLZK040468
Jan 14, 2014Ge Healthcare It
Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by
Terminated
LLZK043415
Dec 26, 2013EOS Imaging
steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in processing 3D X-ray images Product Usage: The sterEOS Workstation is a general system for acceptance , transfer, display and dig
Terminated
LLZK130395
Dec 20, 2013Mckesson Information Solutions LLC
McKesson Radiology 12.0, Picture Archiving Communication System (PACSA).
Terminated
LLZK043146
Dec 17, 2013GE OEC Medical Systems, Inc
InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
Terminated
LLZK960330
Nov 13, 2013Philips Healthcare Informatics, Inc.
Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images an
Terminated
LLZNone listed
Nov 13, 2013GE Healthcare, LLC
AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selecti
Terminated
LLZK052995
K081985 +1
Nov 13, 2013Carestream Health Inc.
Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for h
Terminated
LLZK110919
Nov 13, 2013Carestream Health Inc.
Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for h
Terminated
LLZK110919

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