FDA-cleared K153351
Quantib Brain 1
QUANTIB BV
Quantib Brain is post-processing analysis software for the GE Advantage (AW 4.7) or AW Server (AWS
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2016-06-17
Use case
Neuro MRI radiology AI tools
A buyer-oriented shortlist for neuro mri. Confirm exact intended use and local validation needs before any pilot or procurement decision.
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 K170981
NeuroQuant
CorTechs Labs, Inc
is a fully automat ed MR imaging post -processing medical device software that provides automatic labeling, visualization and volumetric quantification of brain structures and...
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2017-09-07
FDA-cleared K173939
Quantib Brain
Quantib BV
Image analysis/processing for Brain using MRI.
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2018-03-09
FDA-cleared K193290
AI-Rad Companion Brain MR
Siemens Medical Solutions USA, Inc.
Image analysis/processing for Brain using MRI.
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2020-06-17
FDA-cleared K213706
AI-Rad Companion Brain MR
Siemens Healthcare GmBh
Image analysis/processing for Brain using MRI.
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2022-04-15
FDA-cleared K213645
ClearPoint Maestro Brain Model
ClearPoint Neuro, Inc.
Image analysis/processing for Brain using MRI.
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2022-08-08
FDA-cleared K231642
Veuron-Brain-pAb3
Heuron Co., Ltd.
Image analysis/processing for Brain using MRI.
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2023-10-13
FDA-cleared K232305
AI-Rad Companion Brain MR
Siemens Medical Solutions U.S.A.
Image analysis/processing for Brain using MRI.
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2023-10-23
FDA-cleared K232231
QP-Brain®
Quibim S.L.
Image analysis/processing for Brain using MRI.
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2023-12-13
FDA-cleared K251483
SwiftSight-Brain
AIRS Medical Inc.
Image analysis/processing for Brain using MRI.
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2025-09-23
FDA-cleared K251527
Brain WMH
Quantib BV
Image analysis/processing for Brain using MRI.
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2025-09-25
FDA-cleared K252922
Neosoma Brain Mets
Neosoma, Inc.
Image analysis/processing for Brain using MRI.
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2025-12-17