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
Quantification and segmentation radiology AI tools
A buyer-oriented shortlist for quantification and segmentation. Confirm exact intended use and local validation needs before any pilot or procurement decision.
FDA-cleared K161382
LVivo Software Application
DIACARDIO, LTD.
LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular...
- Modality
- MRI
- Anatomy
- Heart
- Decision
- 2016-07-28
FDA-cleared K161322
CT CoPilot
ZEPMED, LLC.
CT CoPilotTM is intended for automatic labeling, visualization and volumetric quantification of segmentable structures from sets of CT images of the brain.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2016-12-07
FDA-cleared K163253
Arterys Cardio DL
ARTERYS INC.
The device is intended to visualize and quantify MRI data in DICOM format.
- Modality
- MRI
- Anatomy
- Vascular
- Decision
- 2017-01-05
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 K163622
Lung Vision
BODY VISION MEDICAL LTD.
cations for Use LungVision System Indications for Use: The LungVision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register...
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2017-05-11
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-authorized DEN220063
Caption Interpretation Automated Ejection Fraction Software
Caption Health, Inc
Quantification/measurement
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-02-24