FDA-Device2021-08-18Class II
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Simpleware Product Group, SYNOPSYS NORTHERN EUROPE
Hazard
A issue (bug) has been identified with the interface and image software which could result in anatomical orientation tags/labels being displayed incorrectly. This could result in operator misunderstanding and errors during resampling or re-alignment of image data
Sold states
US: Nationwide Distribution in the states of CA, FL and countries of : France, United Kingdom, Germany, Australia
Affected count
4 softwares
Manufactured in
Bradninch Hall, Castle Street, Exeter, N/A, United Kingdom
Products
Simpleware ScanIP software. For transfer of imaging information from a medical scanner to an output file, and for simulating/evaluating surgical treatment options.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2253-2021Don't want to check this manually?
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