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3 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Vysioneer Inc.
Authorized purpose: VBrain assists trained professionals in radiation-treatment planning by generating initial contours of known or diagnosed adult brain metastases, meningiomas, or acoustic neuromas and organs at risk from axial T1 contrast-enhanced brain MRI; contours must be finalized on an external DICOM-RT platform.
Vysioneer Inc.
Authorized purpose: VBrain-OAR provides the cleared image-processing and organ-at-risk contouring support described in K212116 for brain radiotherapy planning, with all contours requiring professional review and approval.
Vysioneer Inc.
Authorized purpose: VBrain assists trained professionals in radiation-treatment planning by providing initial contours of known or diagnosed brain tumors on axial contrast-enhanced T1 brain MR images for adults with brain metastases, meningiomas, or acoustic neuromas; manual review remains required.