FDA-cleared K213628

VBrain

Vysioneer Inc.

VBrain assists trained professionals in radiation-treatment planning by generating initial contours of known or diagnosed adult brain metastases, meningiomas, or acoustic neuromas...

Modality
MRI
Anatomy
Brain
Decision
2021-12-16
FDA-cleared K212116

VBrain-OAR

Vysioneer Inc.

VBrain-OAR provides the cleared image-processing and organ-at-risk contouring support described in K212116 for brain radiotherapy planning, with all contours requiring...

Modality
Radiotherapy Planning Imaging
Anatomy
Brain and intracranial organs at risk
Decision
2021-10-12
FDA-cleared K203235

VBrain

Vysioneer Inc.

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...

Modality
Radiotherapy Planning Imaging
Anatomy
Brain tumors represented on contrast-enhanced MRI
Decision
2021-03-19