Quantib BV radiology AI products

FDA-cleared K251527

Brain WMH

Quantib BV

Brain WMH automatically labels, visualizes, and volumetrically quantifies white-matter hyperintensities from T2w FLAIR brain MR and returns segmentations, overlays, and...

Modality: MRI
Anatomy: Brain; white matter hyperintensities
Decision: 2025-09-25

Quantification and segmentation

FDA-cleared K230772

Quantib Prostate

Quantib BV

Support trained medical professionals in processing, visualizing, editing, and interpreting prostate MR studies, including structured PI-RADS scoring; diagnosis must not be made...

Modality: MRI
Anatomy: Prostate, prostatic sub-regions, and user-selected potential lesions.
Decision: 2023-04-17

Prostate imaging

FDA-cleared K221106

Quantib Prostate

Quantib BV

Quantib Prostate versions 1.0 and 2.0 provide processing, visualization, editing, registration, mathematical or statistical analysis, semi-automatic segmentation, volume...

Modality: MRI
Anatomy: Prostate; prostate and prostatic sub-regions
Decision: 2022-05-13

Prostate imaging Quantification and segmentation

FDA-cleared K202501

Quantib Prostate

Quantib BV

Quantib Prostate is image post-processing software for processing, visualizing, and editing prostate MRI images. It supports registered multiparametric-MRI viewing, optional...

Modality: MRI
Anatomy: Prostate
Decision: 2020-10-11

Prostate imaging Quantification and segmentation

FDA-cleared K182564

Quantib ND

Quantib BV

Quantib ND is software for the labeled brain MRI image-analysis workflow, providing release-specific visualization, measurements, or decision-support outputs for professional...

Modality: MRI
Anatomy: Brain
Decision: 2018-12-27

Quantification and segmentation Neuro MRI

FDA-cleared K173939

Quantib Brain

Quantib BV

Automatic brain-structure labeling, visualization, volumetric quantification, and WMH-candidate assessment as complementary information for trained professionals evaluating MR...

Modality: MRI
Anatomy: Brain structures including grey matter, white matter, cerebrospinal fluid, intracranial volume, and white matter hyperintensity candidates
Decision: 2018-03-09

Stroke and ICH triage Quantification and segmentation

FDA-cleared K163013

Quantib Brain 1.2

Quantib BV

Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images; visualizes and quantifies WMH candidates and provides...

Modality: MRI
Anatomy: Brain structures, including grey matter, white matter, cerebrospinal fluid, and white-matter-hyperintensity candidates.
Decision: 2017-01-06

Quantification and segmentation

FDA-cleared K153351

Quantib Brain 1

QUANTIB BV

Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images; visualizes and quantifies WMH candidates and provides...

Modality: MRI
Anatomy: Brain structures, including grey matter, white matter, cerebrospinal fluid, and white-matter-hyperintensity candidates.
Decision: 2016-06-17

Quantification and segmentation