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3 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Olea Medical
Authorized purpose: MR DWI/FLAIR Measurement V1.0 processes brain DWI and FLAIR MRI to calculate ADC maps, segment ADC-hypointense regions, and communicate relative or normalized FLAIR measurements; it is an adjunct and cannot be used alone for diagnosis, treatment, or patient-management decisions.
Olea Medical
Authorized purpose: MR Diffusion Perfusion Mismatch V1.0 is image-processing software for computing parametric maps from MR diffusion-weighted and perfusion-weighted imaging, extracting threshold-based volumes of interest, and automatically calculating mismatch to assist trained radiologists and surgeons with medical-image assessment.
Olea Medical
Authorized purpose: Visualization, analysis, reporting, lesion measurement, kinetic assessment, and MR-guided breast interventional planning; when interpreted by a skilled physician, information may support screening, diagnosis, and intervention planning, but patient management must not rely solely on the results.