Merge Healthcare, Inc.

Versions 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, and 9.0.8

Radiology Devices

2

No

US Nationwide Distribution.

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.

Versions 8.30, 9.0, 9.0.1, 9.0.2, 9.0.3, 9.0.4, 9.0.5, 9.0.6, 9.0.7, 9.0.8, 10.0, 10.0.1, and 10.1 with Issuer of Patient ID (IPID)

Radiology Devices

2

No

US Distribution was made to medical facilities located in GA, IL, MD, MI, MO, OH, TN, and VT. There was no foreign/government/military distribution.

Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI.

Versions: 2.0, 2.1, 2.1.1, 3.1, 3.2, 3.2.4, 3.3, 3.3.1, 3.4, 3.5.1, 3.5.1.1, 3.5.2, 3.5.3, 3.5.4, 3.5.5, 3.6, 3.6.1, 3.6.2, 3.7, 3.7.1, 3.7.2, 3.7.2 Vet, and 3.7.3

Radiology Devices

2

No

Distribution was made to medical facilities in CA, CO, CT, MA, MD, MN, MT, NE, NV, NY NJ, PA, SC, WA, and WI. Foreign distribution was made to Canada, as well as other countries.

Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.

Version 11.0

Radiology Devices

2

No

Distribution was made to medical facilities located in MT, CA, PA, and TX.

DR Systems Unity PACS software, now known as Merge Unity PACS software.

Versions V3.0.2 P3, 3.02, 3.1, 3.2, 3.3, and 3.3.1.

Radiology Devices

2

No

Distribution was made to AZ, CA, ID, IL, IN, MI, MN, and NJ.

Fusion Workstation.; Indicated for the transmission and review of radiological images.