Radiology AI Directory

Regulatory hub

FDA-cleared radiology AI tools

This hub uses the cleaned FDA radiology AI dataset and keeps submission numbers, source links, and unknown fields visible. It should be used as a buyer research starting point, not as clinical, billing, or procurement advice.

FDA-cleared listings 1164
Vendors 525
Latest decision 2026-03-30

How to read a listing

  1. Confirm the FDA file number and decision date before interpreting marketing claims.
  2. Check the intended clinical use against your actual workflow, modality, and patient population.
  3. Treat pricing, deployment, and integration as unknown unless a source confirms them.
  4. Use the correction link when vendor or FDA-source facts have changed.

Representative FDA-cleared listings

Start with a balanced cross-modality sample

FDA-cleared K252148

Butterfly Gestational Age Tool

Butterfly Network, Inc.

FDA product code IYN identifies this device class as System, Imaging, Pulsed Doppler, Ultrasonic. Consult the linked FDA record for the exact authorized indications for use.

Modality
Ultrasound
Anatomy
Obstetric/Fetal
Decision
2026-03-27
Ultrasound workflow
FDA-cleared K253270

Contour ProtégéAI+

Mim Software, Inc.

FDA product code QKB identifies this device class as Radiological Image Processing Software For Radiation Therapy. To provide semi-automatic or fully-automated radiological image...

Modality
Radiotherapy Planning Imaging
Anatomy
N/A
Decision
2026-03-27
Radiotherapy planning
FDA-cleared K253649

Spectral CT Verida Family

Philips Medical Systems Technologies, Ltd.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
N/A
Decision
2026-03-27
CT/CTA workflow
FDA-cleared K253796

Lunit INSIGHT DBT (V1.2)

Lunit, Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2026-03-26
Breast imagingDetection and CADe
FDA-cleared K252099

Trinias

Shimadzu Corporation

FDA product code OWB identifies this device class as Interventional Fluoroscopic X-Ray System. Interventional fluoroscopy Consult the linked FDA record for the exact authorized...

Modality
Fluoroscopy/Angiography
Anatomy
N/A
Decision
2026-03-24
Fluoroscopy/Angiography workflow
FDA-cleared K252538

CEPHX3D

Orca Dental AI, Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2026-03-05
X-ray/Radiography workflow
FDA-cleared K252934

Diagnocat

DGNCT, LLC

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
CBCT
Anatomy
N/A
Decision
2026-01-15
CBCT workflow
FDA-cleared K232023

Momentum Spine

Momentum Health Inc.

FDA product code LDK identifies this device class as Device, Sensing, Optical Contour. Consult the linked FDA record for the exact authorized indications for use.

Modality
Optical Surface Imaging
Anatomy
Spine
Decision
2023-10-04
MSK and bone