The software was distributed nationwide to medical facilities. There was no government/military/foreign distribution.
Description du dispositif
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Hartland, WI. || OfficePACS is intended for the manipulation and displaying of medical images by a suitable licensed and qualified healthcare professional. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. OrthoPACS also uses such images, in conjunction with templates for prosthetic devices, for the purposes of choosing the nature and characteristics of the prosthetic device to be used when planning a potential surgical procedure.
Distribution was made to medical facilities located in AL, AZ, CA, CO, CT, FL GA, ID, IL, KY, MA, MO, NE, NH, NJ, NY, NC, OK, PA, SC, TN, VA, and WA. There was no government/military/foreign distribution.
Description du dispositif
Merge OfficePACS software. The firm name on the label is Merge Healthcare, Heartland, WI.