FDA-cleared K163013

Quantib Brain 1.2

Quantib BV

Quantib Brain is post-processing analysis software for the GE Advantage Workstation (AW 4.7) and AW Server (AWS 3.2) platforms using Volume Viewer Apps. 12.3 Ext 8 (or higher).

Modality
MRI
Anatomy
Brain
Decision
2017-01-06
FDA-cleared K173939

Quantib Brain

Quantib BV

Image analysis/processing for Brain using MRI.

Modality
MRI
Anatomy
Brain
Decision
2018-03-09
FDA-cleared K182564

Quantib ND

Quantib BV

Image analysis/processing.

Modality
MRI
Anatomy
N/A
Decision
2018-12-27
FDA-cleared K202501

Quantib Prostate

Quantib BV

Image analysis/processing for Prostate using MRI.

Modality
MRI
Anatomy
Prostate
Decision
2020-10-11
FDA-cleared K221106

Quantib Prostate

Quantib BV

Image analysis/processing for Prostate using MRI.

Modality
MRI
Anatomy
Prostate
Decision
2022-05-13
FDA-cleared K230772

Quantib Prostate

Quantib BV

Image analysis/processing for Prostate using MRI.

Modality
MRI
Anatomy
Prostate
Decision
2023-04-17
FDA-cleared K251527

Brain WMH

Quantib BV

Image analysis/processing for Brain using MRI.

Modality
MRI
Anatomy
Brain
Decision
2025-09-25