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) |
|---|---|---|---|
| Aug 27, 2015 | GE 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 |
LLZ | None listed |
| Aug 27, 2015 | GE 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 |
LLZ | None listed |
| Jul 23, 2015 | Merge 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 |
LLZ | K041935 |
| Jul 13, 2015 | AGFA 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 |
LLZ | None listed |
| Jul 3, 2015 | NordicNeuroLab 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 |
LLZ | K082441 |
| Jul 2, 2015 | Siemens 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 |
LLZ | K071114 K081734 |
| Jun 15, 2015 | Philips 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 |
LLZ | K140808 |
| Jun 3, 2015 | Siemens 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 |
LLZ | K092519 K123375 |
| Mar 30, 2015 | Siemens 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 |
LLZ | K093612 K132532 +1 |
| Mar 4, 2015 | iCAD, Inc. DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 Terminated |
LLZ | K090223 |
| Feb 26, 2015 | GE 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 |
LLZ | K043415 |
| Feb 9, 2015 | TeraRecon, 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 |
LLZ | K121916 |
| Jan 28, 2015 | Siemens 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 |
LLZ | K093612 K132532 +1 |
| Dec 17, 2014 | Carestream Health, Inc. CARESTREAM DIRECTVIEW CR Software
Generates digital mammographic images that can be used for screening and diagnosis of breast cancer. Terminated |
LLZ | K020635 K923554 |
| Dec 16, 2014 | Philips 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 |
LLZ | K140808 |
| Dec 16, 2014 | Philips 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 |
LLZ | K132165 |
| Dec 15, 2014 | NordicNeuroLab 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 |
LLZ | K123306 |
| Dec 15, 2014 | Siemens 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 |
LLZ | K082430 K093612 +1 |
| Oct 15, 2014 | Merge 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 |
LLZ | K012211 K020995 |
| Sep 17, 2014 | NordicNeuroLab 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 |
LLZ | K133910 |
| Sep 12, 2014 | NordicNeuroLab AS nordicICE 2.3.14
Image processing software package used by trained professionals, including physicians and medical technicians. Terminated |
LLZ | K082441 |
| Aug 19, 2014 | Intelerad 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 |
LLZ | K083520 |
| Aug 16, 2014 | Philips Healthcare Informatics, Inc. Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage. Terminated |
LLZ | K111804 |
| Jul 30, 2014 | Brainlab 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 |
LLZ | K093117 |
| Jul 28, 2014 | Mckesson 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 |
LLZ | K043146 |
| Jul 23, 2014 | Siemens 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 |
LLZ | K082430 |
| Jul 23, 2014 | Philips 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 |
LLZ | K152165 |
| Jul 23, 2014 | Philips 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 |
LLZ | K152165 |
| Jun 6, 2014 | Mckesson 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 |
LLZ | K043146 |
| May 28, 2014 | GE 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 |
LLZ | K043415 |
| May 27, 2014 | AGFA 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 |
LLZ | K050228 |
| May 16, 2014 | Siemens 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 |
LLZ | K033831 K042832 +1 |
| May 13, 2014 | Mckesson 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 |
LLZ | K043146 |
| May 13, 2014 | Siemens 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 |
LLZ | K023772 K102150 |
| Apr 25, 2014 | GE 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 |
LLZ | K121762 |
| Apr 24, 2014 | Philips 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 |
LLZ | K072960 |
| Mar 25, 2014 | Velocity 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 |
LLZ | K081076 |
| Mar 18, 2014 | Siemens Medical Solutions USA, Inc syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673 Terminated |
LLZ | K023772 K102150 |
| Feb 12, 2014 | Mckesson Information Solutions LLC Horizon Medical Imaging, Picture Archive Communication System (PACS). Terminated |
LLZ | K043146 |
| Feb 3, 2014 | AGFA Corp. IMPAX RIS QDOC 5.8 Terminated |
LLZ | K111945 |
| Jan 15, 2014 | Ge 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 |
LLZ | K052618 |
| Jan 14, 2014 | GE 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 |
LLZ | K040468 |
| Jan 14, 2014 | Ge 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 |
LLZ | K043415 |
| Dec 26, 2013 | EOS 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 |
LLZ | K130395 |
| Dec 20, 2013 | Mckesson Information Solutions LLC McKesson Radiology 12.0, Picture Archiving Communication System (PACSA). Terminated |
LLZ | K043146 |
| Dec 17, 2013 | GE OEC Medical Systems, Inc InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA), Terminated |
LLZ | K960330 |
| Nov 13, 2013 | Philips 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 |
LLZ | None listed |
| Nov 13, 2013 | GE 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 |
LLZ | K052995 K081985 +1 |
| Nov 13, 2013 | Carestream 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 |
LLZ | K110919 |
| Nov 13, 2013 | Carestream 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 |
LLZ | K110919 |
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