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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 12, 2016Ortho Kinematics, Inc
Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files
Open, Classified
LLZK133875
Aug 12, 2016Philips Electronics North America Corporation
PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).
Terminated
LLZK964124
Jul 29, 2016Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, Wisconsin. Merge PACS 6.0 is software intended to create and display two-dimensional and three-dimensional images of an
Terminated
LLZK082144
Jul 14, 2016Merge Healthcare, Inc.
Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and
Terminated
LLZK053281
Jul 11, 2016Merge Healthcare, Inc.
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.
Terminated
LLZK033825
Jul 8, 2016Merge Healthcare, Inc.
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualif
Terminated
LLZK033825
Jun 29, 2016Siemens Medical Solutions USA, Inc
Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,
Terminated
LLZK093612
Jun 23, 2016Siemens Medical Solutions USA, Inc
Syngo.via, picture archiving and communications system software controlled. Intended to be used for viewing, manipulation, communication, and storage of medical images.
Terminated
LLZK092519
K123375
Jun 6, 2016Siemens Medical Solutions USA, Inc
SYNGO Breast Care, visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
Terminated
LLZK123420
May 25, 2016Merge Healthcare, Inc.
iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI.
Terminated
LLZK092915
May 10, 2016Fujifilm Medical Systems U.S.A., Inc.
Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujif
Terminated
LLZK112439
May 6, 2016Novarad Corporation
NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation
Terminated
LLZK132853
May 4, 2016Siemens Medical Solutions USA, Inc
Syngo Dynamics; Kinetdx Picture Archiving and Communications System
Terminated
LLZK023772
May 2, 2016Carestream Health Inc
CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/
Terminated
LLZK100094
May 2, 2016Carestream Health Inc
CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/POC&VITA: REF/Catalog # 1036508; MINI-PACS/F IMG ST/CLASSIC/INDIA: REF/Catalog # 1036417; MINI-PACS/F
Terminated
LLZK100094
Apr 7, 2016Siemens Medical Solutions USA, Inc
A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.
Terminated
LLZK071114
K081734
Apr 4, 2016Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare.
Terminated
LLZK082144
Apr 4, 2016Merge Healthcare, Inc.
Merge Cardio software.
Terminated
LLZK051649
Apr 4, 2016Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
Terminated
LLZK082144
Mar 28, 2016Merge Healthcare, Inc.
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and rep
Terminated
LLZK051649
Mar 28, 2016Merge Healthcare, Inc.
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measureme
Terminated
LLZK051649
Mar 28, 2016Merge 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
Mar 28, 2016Merge Healthcare, Inc.
Merge PACS software. Product Usage: Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital moda
Terminated
LLZK082144
Mar 23, 2016Siemens Medical Solutions USA, Inc
syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnos
Terminated
LLZK143319
Feb 23, 2016Siemens Medical Solutions USA, Inc
Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and ar
Terminated
LLZK093612
K132532
Feb 19, 2016Siemens Medical Solutions USA, Inc
software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including qua
Terminated
LLZK023772
K102150
Feb 18, 2016Mckesson Medical Immaging
McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.
Terminated
LLZK043146
Feb 5, 2016Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digit
Terminated
LLZK082144
Jan 30, 2016Merge Healthcare, Inc.
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Terminated
LLZK092954
Jan 30, 2016Merge Healthcare, Inc.
Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
Terminated
LLZK051649
Jan 30, 2016Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.
Terminated
LLZK053281
Jan 30, 2016Merge Healthcare, Inc.
Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
Terminated
LLZK082144
Jan 30, 2016Merge Healthcare, Inc.
iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet
Terminated
LLZK033825
K082144 +1
Jan 30, 2016Merge Healthcare, Inc.
iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet
Terminated
LLZK033825
K082144 +1
Jan 30, 2016Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally
Terminated
LLZK082144
Jan 25, 2016Siemens Medical Solutions USA, Inc
Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptan
Terminated
LLZK023772
K102150
Jan 6, 2016Siemens Medical Solutions USA, Inc
Software version VD10E for Syngo X-Workplace; Picture archiving and communication system.
Terminated
LLZK143319
Dec 17, 2015Merge Healthcare, Inc.
RadSuite, a picture archive and communications system. Model Numbers Versions 5.30.0, 5.30.1, 5.30.2, 5.30.2 SB0344, 5.30.3, 5.30.4, 5.30.4 HF0418E, 5.30.5, 5.30.5 HF0404E, 5.30.5 HF0413E, 5.30.5 HF39
Terminated
LLZK053281
Nov 20, 2015Siemens Medical Solutions USA, Inc
Syngo Imaging VB36D_HF02. Radiological image processing system.
Terminated
LLZK071114
K081734
Nov 17, 2015Siemens Medical Solutions USA, Inc
Syngo Imaging XS is a Picture Archiving and Communication System (PACS)
Terminated
LLZK082430
Oct 26, 2015Merge Healthcare, Inc.
Merge Cardio with software version 10.1 LA.
Terminated
LLZK051649
Oct 15, 2015Merge Healthcare, Inc.
DR Systems Unity PACS software, now known as Merge Unity PACS software.
Terminated
LLZK041935
Oct 5, 2015GE Healthcare
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, comm
Terminated
LLZK082318
K121387
Oct 1, 2015Merge Healthcare, Inc.
Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images,
Terminated
LLZK051649
Sep 28, 2015GE Healthcare
The Centricity Universal Viewer Version is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed an
Terminated
LLZK150420
Sep 28, 2015GE Healthcare
The Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, process
Terminated
LLZK123174
Sep 22, 2015Merge Healthcare, Inc.
Merge Cardio software. Product Usage: Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and rep
Terminated
LLZK051649
Sep 21, 2015Brainlab AG
Digital Lightbox, BrainLAB system, image processing, radiological Product Usage: The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to a
Terminated
LLZK093117
Sep 2, 2015Siemens Medical Solutions USA, Inc
Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, dis
Terminated
LLZK093612
Sep 1, 2015AGFA Healthcare Corp.
IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Numbe
Terminated
LLZK050228

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