Radiology AI Directory

Vendor

Quantib B.V.

2 FDA-cleared listings in this directory.

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FDA-cleared K253682

DeepHealth ProstateAI

Quantib B.V.

Concurrent-reading aid for trained physicians detecting and characterizing prostate-cancer lesions in adult males aged 40 years and older undergoing prostate MRI.

Modality
MRI
Anatomy
Prostate and lesions within or extending from the prostate
Decision
2026-04-29
Prostate imagingDetection and CADe
FDA-cleared K213737

Quantib ND

Quantib B.V.

Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images, with complementary segmentations, visualizations, and volume...

Modality
MRI
Anatomy
Brain structures and white matter hyperintensities
Decision
2022-01-14
Quantification and segmentation