AMICAS PACS, VERSION 6.0— 510(k) K082144
Substantially EquivalentAmicas, Inc.
FDA 510(k) clearance K082144 for AMICAS PACS, VERSION 6.0, Substantially Equivalent on 2008-09-05. Applicant: Amicas, Inc.. Device class: 2.
Clearance details
- Applicant
- Amicas, Inc.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
Recent devices under product code LLZ
view allMore clearances from Amicas, Inc.
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K082144
K-number listed on FDA's recall record- Z-2601-2017 — Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Z-2590-2017 — Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Z-2591-2017 — 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, including digital mammography
- Z-1176-2017 — Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI.
- Z-1431-2017 — Merge PACS software. The firm name on the label is Merge Healthcare.
- Z-0599-2017 — 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 modalities, including digital mammography.
- Z-0726-2017 — 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, including digital mammography.
- Z-2363-2016 — 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 digitally acquired images.
- Z-2301-2016 — 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 acquired images.
- Z-2303-2016 — 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 anatomy from a series of digitally acquired images.
- Z-2379-2016 — Merge PACS software. Product was distributed under the AMICAS label, Brighton, MA, but labeling was later changed to Merge Healthcare, Hartland, WI.
- Z-2531-2016 — 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) networks.
- Z-2532-2016 — 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) networks.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082144.
Data sourced from openFDA. This site is unofficial and independent of the FDA.