FDA-Device2023-10-25Class II
Functional MR V1.0
OLEA MEDICAL
Hazard
When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting multiple volumes of interest, a functional magnetic resonance software bug may cause file contents and associated series descriptions to not match, which could lead to a misinterpretation of clinical data.
Sold states
US: MI, MA
Affected count
2
Manufactured in
93 AVANUE DU SORBIER,, ZONE ATHELIA IV, LA CIOTAT, N/A, France
Products
Functional MR V1.0
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0122-2024Don't want to check this manually?
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