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FDA-cleared K252922

Neosoma Brain Mets

Neosoma, Inc.

Authorized purpose: Neosoma Brain Mets semi-automatically segments and contours previously diagnosed brain metastases on T1 post-contrast brain MRI to support radiation-oncology treatment planning.

Modality
MRI
Anatomy
Brain; previously diagnosed brain metastases
Decision
2025-12-17
FDA-cleared K221738

NS-HGlio

Neosoma Inc.

Authorized purpose: Semi-automatic labeling, visualization, and volumetric quantification of high-grade brain glioma, including WHO grade 3 astrocytoma, grade 4 astrocytoma, and grade 4 glioblastoma, from standard MRI in patients aged 18 or older with pathologically proven high-grade glioma; prior measurements may be compared when available, but the device is not for primary diagnosis.

Modality
MRI
Anatomy
Brain; high-grade glioma and its subcomponents
Decision
2022-09-27