FDA-Device2021-04-14Class II
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
Fujifilm Medical Systems U.S.A., Inc.
Hazard
The wrong patient information may be displayed in the viewer or PowerJacket.
Sold states
Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY and the countries of United Arab Emirates, Angola, Argentina, Austria, Australia, Belgium, Bermuda, Brazil, Canada, Switzerland, Chile, Colombia, Costa Rica, Czechia, Germany, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Israel, India, Italy, Jordan, Japan, Kuwait, Malta, Mexico, Malaysia, Netherlands, Peru, Philippines, Pakistan, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovenia, Slovakia, El Salvador, Thailand, Turkey, Uruguay, South Africa, Zimbabwe.
Affected count
839 systems
Manufactured in
81 Hartwell Ave Ste 300, N/A, Lexington, MA, United States
Products
Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1348-2021Don't want to check this manually?
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