FDA-Device2025-03-12Class II
MIM software; System, Image Processing, Radiological
MIM Software Inc
Hazard
In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV) within MIM Software versions 7.2.0 through 7.2.6.could result.
Sold states
Worldwide distribution - United States Nationwide and the countries of Australia, Belgium, Bolivia, Canada, China, Croatia, Czech Republic, Denmark, France, Germany, Greece, Israel, Italy, Japan, Mexico, Netherlands, Poland, Russia, Spain, Sweden, United Kingdom, Finland, Hong Kong.
Affected count
352 units
Manufactured in
25800 Science Park Dr Ste 180, Cleveland, OH, United States
Products
MIM software; System, Image Processing, Radiological
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1267-2025Don't want to check this manually?
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