FDA-Device2016-12-14Class II

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.

Merge Healthcare, Inc.
Hazard

Cut lines on the image may present horizontally rather than vertically.

Sold states
Worldwide Distribution - US (nationwide) Canada and foreign distribution
Affected count
537 sites potentially have the affected versions
Manufactured in
900 Walnut Ridge Dr, N/A, Hartland, WI, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0726-2017

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