FDA-Device2017-03-29Class II
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 reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
Merge Healthcare, Inc.
Hazard
Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation.
Sold states
US Nationwide Distribution.
Affected count
89 sites potentially have the affected software
Manufactured in
900 Walnut Ridge Dr, Hartland, WI, United States
Products
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 reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1517-2017Don't want to check this manually?
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