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) |
|---|---|---|---|
| Mar 20, 2018 | Siemens Medical Solutions USA, Inc Syngo.via. Medical Device Software. Picture archiving and communications system. Terminated |
LLZ | K123375 |
| Feb 23, 2018 | GE Healthcare GE Healthcare Centricity PACS-IW, Model Numbers:
(a) 2052831-00X
(b) 2049588-008
Product Usage:
Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and Terminated |
LLZ | K082318 |
| Feb 20, 2018 | Siemens Medical Solutions USA, Inc Syngo.plaza software
Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images Terminated |
LLZ | K132532 |
| Feb 20, 2018 | Siemens Medical Solutions USA, Inc Syngo.plaza software VB10A model numbers: 10863171, 10863172, 10863173
Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, dist Terminated |
LLZ | K132532 |
| Jan 25, 2018 | GE Healthcare Centricity Universal Viewer
Product Usage:
Usage:
Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Image Terminated |
LLZ | K150420 |
| Jan 25, 2018 | GE Healthcare Centricity PACS-IW with Universal Viewer
Product Usage:
Usage:
Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging s Terminated |
LLZ | K123174 |
| Jan 10, 2018 | Siemens Medical Solutions USA, Inc Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmod Terminated |
LLZ | K123375 |
| Aug 31, 2017 | Siemens Medical Solutions USA, Inc Syngo.via systems with SW VB20A Terminated |
LLZ | K123375 |
| Aug 23, 2017 | Siemens Medical Solutions USA, Inc Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173
Product Usage:
Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, re Terminated |
LLZ | K132532 |
| Aug 18, 2017 | Siemens Medical Solutions USA, Inc Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173
Syngo.plaza is a Picture Archiving and Communication System (PAC Terminated |
LLZ | K132532 |
| Aug 18, 2017 | Merge Healthcare, Inc. Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Merge Unity is a medical image and information management system Terminated |
LLZ | K041935 K143318 |
| Aug 7, 2017 | Merge Healthcare, Inc. Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system Terminated |
LLZ | K041935 K143318 |
| Jul 25, 2017 | Siemens Medical Solutions USA, Inc. Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medic Terminated |
LLZ | K081734 |
| May 24, 2017 | Merge Healthcare, Inc. Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K022881 K082144 +1 |
| May 24, 2017 | Merge Healthcare, Inc. Merge OrthoPACS software. Terminated |
LLZ | None listed |
| May 22, 2017 | Siemens Medical Solutions USA, Inc Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171
Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communic Terminated |
LLZ | K132532 |
| May 22, 2017 | Merge Healthcare, Inc. Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
Intended to be used to acquire, store, print, transfer, and archive clinical information. Terminated |
LLZ | K051649 |
| May 8, 2017 | Merge Healthcare, Inc. Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication, and storage of studies produced by digital modalities, includi Terminated |
LLZ | K082144 |
| May 8, 2017 | Merge Healthcare, Inc. Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K082144 |
| Apr 11, 2017 | Ge Medical Systems Information T Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the syste Terminated |
LLZ | K083018 |
| Mar 27, 2017 | Siemens Medical Solutions USA, Inc Syngo.via, Picture archiving and communication system
Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a Terminated |
LLZ | K123375 |
| Mar 27, 2017 | Siemens Medical Solutions USA, Inc Syngo.x, Picture archiving and communication system
Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a st Terminated |
LLZ | K092519 |
| Mar 20, 2017 | Merge Healthcare, Inc. Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K051649 |
| Mar 13, 2017 | Zimmer Biomet, Inc. Orthosize Templating Version 1.2.6
Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery. Terminated |
LLZ | K120115 |
| Mar 10, 2017 | Siemens Medical Solutions USA, Inc Syngo.plaza, Picture Archiving and Communications System (PACS)
Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, Terminated |
LLZ | K093612 |
| Mar 9, 2017 | Merge Healthcare, Inc. DR Systems Unity PACS software, now known as Merge Unity PACS Terminated |
LLZ | K041935 |
| Mar 8, 2017 | Merge Healthcare, Inc. Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K051649 |
| Mar 3, 2017 | Merge Healthcare, Inc. Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K051649 |
| Mar 2, 2017 | Ortho Kinematics, Inc Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254.
Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files. Open, Classified |
LLZ | K133875 |
| Mar 2, 2017 | Merge Healthcare, Inc. DR Systems Unity PACS software, now known as Merge Unity PACS.
Product Usage:
Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printin Terminated |
LLZ | K041935 |
| Feb 9, 2017 | Merge Healthcare, Inc. Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K053281 |
| Jan 18, 2017 | DICOM GRID INC Ambra PACS
UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R
Software Version Number: V3.16.13.0
Intended for use as a primary diagnostic and analysis tool for diagnostic images. Terminated |
LLZ | K152977 |
| Jan 11, 2017 | Ortho Kinematics, Inc Vertebral Motion Analyzer (VMA) Version 2.3.252.
VMA software is a quantitative imaging software application intended to be used to process digital image files. Open, Classified |
LLZ | K133875 |
| Jan 11, 2017 | Siemens Medical Solutions USA, Inc Syngo.plaza, picture archiving and communications system. Terminated |
LLZ | K093612 |
| Dec 22, 2016 | AGFA Healthcare Corp. IMPAX Cardiovascular
The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with rep Terminated |
LLZ | K050228 |
| Dec 21, 2016 | Merge Healthcare, Inc. Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K022881 |
| Dec 2, 2016 | Mckesson Medical Imaging McKesson Radiology 12.2 - Picture Archive Communication System (PACS) Terminated |
LLZ | K140909 |
| Nov 21, 2016 | GE Healthcare, LLC Prestilix Terminated |
LLZ | K924310 |
| Oct 20, 2016 | Merge Healthcare, Inc. Merge, eFilm Workstation and eFilm Lite
eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and da Terminated |
LLZ | K020995 |
| Sep 27, 2016 | Siemens Medical Solutions USA, Inc Syngo.plaza VB10A, Picture Archiving and Communication System Terminated |
LLZ | K132532 |
| Sep 27, 2016 | Siemens Medical Solutions USA, Inc Syngo.plaza, Picture Archiving and Communication System Terminated |
LLZ | K093612 |
| Sep 22, 2016 | Mckesson Medical Imaging Group McKesson Radiology, versions 12.1.1 and 12.2
McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information management application that is inten Terminated |
LLZ | K043146 |
| Sep 21, 2016 | Siemens Medical Solutions USA, Inc Syngo.via picture archiving and communication system
Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. Terminated |
LLZ | K123375 |
| Sep 21, 2016 | Siemens Medical Solutions USA, Inc Syngo.x picture archiving and communication system
Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. Terminated |
LLZ | K092519 |
| Sep 15, 2016 | Fujifilm Medical Systems U.S.A., Inc. Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx
Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image Terminated |
LLZ | K112439 |
| Sep 14, 2016 | Siemens Medical Solutions USA, Inc Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Terminated |
LLZ | K132532 |
| Sep 2, 2016 | Merge Healthcare, Inc. Merge RadSuite software. Radiological image processing system. Terminated |
LLZ | K053281 |
| Sep 1, 2016 | Merge Healthcare, Inc. Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system. Terminated |
LLZ | K051649 |
| Aug 25, 2016 | Novarad Corporation NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS)
Product Usage NovaPACS is a picture archiving and communication system Terminated |
LLZ | K132853 |
| Aug 23, 2016 | Merge Healthcare, Inc. RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K053281 |
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