510(k) K082144 ยท LLZ System, Image Processing, Radiological
AMICAS PACS, VERSION 6.0
| Applicant | Amicas, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Sep 5, 2008 |
| Received | Jul 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082144
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 24, 2017 | Merge Healthcare, Inc. Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | None listed |
| May 8, 2017 | Merge Healthcare, Inc. Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | None listed |
| 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 | None listed |
| 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 | None listed |
| Apr 4, 2016 | Merge Healthcare, Inc. Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Terminated |
LLZ | None listed |
| Apr 4, 2016 | Merge Healthcare, Inc. Merge PACS software. The firm name on the label is Merge Healthcare. Terminated |
LLZ | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.