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 12, 2016 | Ortho 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 |
LLZ | K133875 |
| Aug 12, 2016 | Philips 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 |
LLZ | K964124 |
| Jul 29, 2016 | Merge 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 |
LLZ | K082144 |
| Jul 14, 2016 | Merge 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 |
LLZ | K053281 |
| Jul 11, 2016 | Merge Healthcare, Inc. Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI. Terminated |
LLZ | K033825 |
| Jul 8, 2016 | Merge 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 |
LLZ | K033825 |
| Jun 29, 2016 | Siemens Medical Solutions USA, Inc Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173, Terminated |
LLZ | K093612 |
| Jun 23, 2016 | Siemens 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 |
LLZ | K092519 K123375 |
| Jun 6, 2016 | Siemens 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 |
LLZ | K123420 |
| May 25, 2016 | Merge Healthcare, Inc. iConnect Access software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K092915 |
| May 10, 2016 | Fujifilm 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 |
LLZ | K112439 |
| May 6, 2016 | Novarad Corporation NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation Terminated |
LLZ | K132853 |
| May 4, 2016 | Siemens Medical Solutions USA, Inc Syngo Dynamics; Kinetdx Picture Archiving and Communications System Terminated |
LLZ | K023772 |
| May 2, 2016 | Carestream 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 |
LLZ | K100094 |
| May 2, 2016 | Carestream 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 |
LLZ | K100094 |
| Apr 7, 2016 | Siemens 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 |
LLZ | K071114 K081734 |
| Apr 4, 2016 | Merge Healthcare, Inc. Merge PACS software. The firm name on the label is Merge Healthcare. Terminated |
LLZ | K082144 |
| Apr 4, 2016 | Merge Healthcare, Inc. Merge Cardio software. Terminated |
LLZ | K051649 |
| Apr 4, 2016 | Merge Healthcare, Inc. Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K082144 |
| Mar 28, 2016 | Merge 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 |
LLZ | K051649 |
| Mar 28, 2016 | Merge 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 |
LLZ | K051649 |
| Mar 28, 2016 | 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 |
| Mar 28, 2016 | Merge 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 |
LLZ | K082144 |
| Mar 23, 2016 | Siemens 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 |
LLZ | K143319 |
| Feb 23, 2016 | Siemens 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 |
LLZ | K093612 K132532 |
| Feb 19, 2016 | Siemens 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 |
LLZ | K023772 K102150 |
| Feb 18, 2016 | Mckesson 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 |
LLZ | K043146 |
| Feb 5, 2016 | Merge 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 |
LLZ | K082144 |
| Jan 30, 2016 | Merge Healthcare, Inc. CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | K092954 |
| Jan 30, 2016 | Merge Healthcare, Inc. Merge Cardio software.
Product Usage:
Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system. Terminated |
LLZ | K051649 |
| Jan 30, 2016 | Merge 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 |
LLZ | K053281 |
| Jan 30, 2016 | Merge 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 |
LLZ | K082144 |
| Jan 30, 2016 | Merge 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 |
LLZ | K033825 K082144 +1 |
| Jan 30, 2016 | Merge 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 |
LLZ | K033825 K082144 +1 |
| Jan 30, 2016 | Merge 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 |
LLZ | K082144 |
| Jan 25, 2016 | Siemens 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 |
LLZ | K023772 K102150 |
| Jan 6, 2016 | Siemens Medical Solutions USA, Inc Software version VD10E for Syngo X-Workplace; Picture archiving and communication system. Terminated |
LLZ | K143319 |
| Dec 17, 2015 | Merge 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 |
LLZ | K053281 |
| Nov 20, 2015 | Siemens Medical Solutions USA, Inc Syngo Imaging VB36D_HF02. Radiological image processing system. Terminated |
LLZ | K071114 K081734 |
| Nov 17, 2015 | Siemens Medical Solutions USA, Inc Syngo Imaging XS is a Picture Archiving and Communication System (PACS) Terminated |
LLZ | K082430 |
| Oct 26, 2015 | Merge Healthcare, Inc. Merge Cardio with software version 10.1 LA. Terminated |
LLZ | K051649 |
| Oct 15, 2015 | Merge Healthcare, Inc. DR Systems Unity PACS software, now known as Merge Unity PACS software. Terminated |
LLZ | K041935 |
| Oct 5, 2015 | GE 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 |
LLZ | K082318 K121387 |
| Oct 1, 2015 | Merge 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 |
LLZ | K051649 |
| Sep 28, 2015 | GE 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 |
LLZ | K150420 |
| Sep 28, 2015 | GE 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 |
LLZ | K123174 |
| Sep 22, 2015 | Merge 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 |
LLZ | K051649 |
| Sep 21, 2015 | Brainlab 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 |
LLZ | K093117 |
| Sep 2, 2015 | Siemens 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 |
LLZ | K093612 |
| Sep 1, 2015 | AGFA 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 |
LLZ | K050228 |
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