FDA-Device2020-06-17Class II
IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
Philips Healthcare Informatics, Inc.
Hazard
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Sold states
Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, FL, LA, MA, MI, MO, NC, NH, NY, OR, and TX. There was government distribution but no military distribution. The countries of Canada, Brazil, Ireland, New Zealand, United Arab Emirates, and the United Kingdom.
Affected count
26 units
Manufactured in
4430 Rosewood Drive Suite 200, N/A, Pleasanton, CA, United States
Products
IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2338-2020Don't want to check this manually?
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