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)
Mar 20, 2018Siemens Medical Solutions USA, Inc
Syngo.via. Medical Device Software. Picture archiving and communications system.
Terminated
LLZK123375
Feb 23, 2018GE 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
LLZK082318
Feb 20, 2018Siemens 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
LLZK132532
Feb 20, 2018Siemens 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
LLZK132532
Jan 25, 2018GE 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
LLZK150420
Jan 25, 2018GE 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
LLZK123174
Jan 10, 2018Siemens 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
LLZK123375
Aug 31, 2017Siemens Medical Solutions USA, Inc
Syngo.via systems with SW VB20A
Terminated
LLZK123375
Aug 23, 2017Siemens 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
LLZK132532
Aug 18, 2017Siemens 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
LLZK132532
Aug 18, 2017Merge 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
LLZK041935
K143318
Aug 7, 2017Merge 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
LLZK041935
K143318
Jul 25, 2017Siemens 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
LLZK081734
May 24, 2017Merge Healthcare, Inc.
Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Terminated
LLZK022881
K082144 +1
May 24, 2017Merge Healthcare, Inc.
Merge OrthoPACS software.
Terminated
LLZNone listed
May 22, 2017Siemens 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
LLZK132532
May 22, 2017Merge 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
LLZK051649
May 8, 2017Merge 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
LLZK082144
May 8, 2017Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Terminated
LLZK082144
Apr 11, 2017Ge 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
LLZK083018
Mar 27, 2017Siemens 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
LLZK123375
Mar 27, 2017Siemens 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
LLZK092519
Mar 20, 2017Merge Healthcare, Inc.
Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.
Terminated
LLZK051649
Mar 13, 2017Zimmer Biomet, Inc.
Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
Terminated
LLZK120115
Mar 10, 2017Siemens 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
LLZK093612
Mar 9, 2017Merge Healthcare, Inc.
DR Systems Unity PACS software, now known as Merge Unity PACS
Terminated
LLZK041935
Mar 8, 2017Merge Healthcare, Inc.
Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI.
Terminated
LLZK051649
Mar 3, 2017Merge Healthcare, Inc.
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI.
Terminated
LLZK051649
Mar 2, 2017Ortho 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
LLZK133875
Mar 2, 2017Merge 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
LLZK041935
Feb 9, 2017Merge Healthcare, Inc.
Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Terminated
LLZK053281
Jan 18, 2017DICOM 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
LLZK152977
Jan 11, 2017Ortho 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
LLZK133875
Jan 11, 2017Siemens Medical Solutions USA, Inc
Syngo.plaza, picture archiving and communications system.
Terminated
LLZK093612
Dec 22, 2016AGFA 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
LLZK050228
Dec 21, 2016Merge Healthcare, Inc.
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
Terminated
LLZK022881
Dec 2, 2016Mckesson Medical Imaging
McKesson Radiology 12.2 - Picture Archive Communication System (PACS)
Terminated
LLZK140909
Nov 21, 2016GE Healthcare, LLC
Prestilix
Terminated
LLZK924310
Oct 20, 2016Merge 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
LLZK020995
Sep 27, 2016Siemens Medical Solutions USA, Inc
Syngo.plaza VB10A, Picture Archiving and Communication System
Terminated
LLZK132532
Sep 27, 2016Siemens Medical Solutions USA, Inc
Syngo.plaza, Picture Archiving and Communication System
Terminated
LLZK093612
Sep 22, 2016Mckesson 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
LLZK043146
Sep 21, 2016Siemens 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
LLZK123375
Sep 21, 2016Siemens 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
LLZK092519
Sep 15, 2016Fujifilm 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
LLZK112439
Sep 14, 2016Siemens 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
LLZK132532
Sep 2, 2016Merge Healthcare, Inc.
Merge RadSuite software. Radiological image processing system.
Terminated
LLZK053281
Sep 1, 2016Merge Healthcare, Inc.
Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
Terminated
LLZK051649
Aug 25, 2016Novarad 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
LLZK132853
Aug 23, 2016Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Terminated
LLZK053281

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