Radiology AI Directory

Use case

Prostate imaging radiology AI tools

A buyer-oriented shortlist for prostate imaging. Confirm exact intended use and local validation needs before any pilot or procurement decision.

FDA-cleared K170250

SmartTarget

SmartTarget, Ltd.

SmartTarget ,QGLFDWLRQVIRU8VH(Describe) The SmartTarget device is intended as an accessory for image-guided interventional and diagnostic procedures involving the prostate gland,...

Modality
CT/CTA
Anatomy
Prostate
Decision
2017-06-07
Prostate imaging
FDA-cleared K202501

Quantib Prostate

Quantib BV

Image analysis/processing for Prostate using MRI.

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

Quantib Prostate

Quantib BV

Image analysis/processing for Prostate using MRI.

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

Quantib Prostate

Quantib BV

Image analysis/processing for Prostate using MRI.

Modality
MRI
Anatomy
Prostate
Decision
2023-04-17
Prostate imaging
FDA-cleared K233196

Medihub Prostate

JLK Inc.

Image analysis/processing for Prostate using MRI.

Modality
MRI
Anatomy
Prostate
Decision
2024-06-21
Prostate imaging
FDA-cleared K243853

Clarius Prostate AI

Clarius Mobile Health Corp.

Image analysis/processing for Prostate using MRI.

Modality
MRI
Anatomy
Prostate
Decision
2025-04-16
Prostate imaging