AI devices with FDA product code QDQ — Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Product code QDQ (“Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer” in openFDA) covers 36 devices on the FDA AI-enabled list, from 18 companies. Most are reviewed by the Radiology panel (36). The most recent decision was MammoScreen® (5) on June 26, 2026.
36AI devices
13Companies
2018First decision
2026-06-26Latest decision
Trend: devices per year
201820192020202120222023202420252026
Top companies
All 36 devices, newest first
- MammoScreen® (5)Therapixel · Radiology
- Saige-DxDeepHealth, Inc. · Radiology
- DeepHealth ProstateAIQuantib B.V. · Radiology
- Lunit INSIGHT MMG (v1.1.10)Lunit, Inc. · Radiology
- Lunit INSIGHT DBT (V1.2)Lunit, Inc. · Radiology
- Median LCS (internal name) / eyonis LCS (trade name) (1.0)Median Technologies · Radiology
- Saige-DxDeepHealth, Inc. · Radiology
- Genius AI Detection 2.0Hologic, Inc. · Radiology
- MammoScreen® (4)Therapixel · Radiology
- QP-Prostate® CADQuibim S.L. · Radiology
- Prostate MR AI (VA10A)Siemens Healthcare GmbH · Radiology
- Saige-Dx (3.1.0)DeepHealth, Inc. · Radiology
- Transpara (2.1.0)ScreenPoint Medical B.V. · Radiology
- Saige-DxDeepHealth, Inc · Radiology
- ProFound Detection (V4.0)iCAD, Inc. · Radiology
- Lunit INSIGHT DBT v1.1Lunit Inc. · Radiology
- See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte. Ltd. · Radiology
- MammoScreen® (3)Therapixel · Radiology
- Lunit INSIGHT DBTLunit Inc. · Radiology
- Genius AI Detection 2.0 with CC-MLO CorrelationHologic, Inc. · Radiology
- Genius AI Detection 2.0Hologic, Inc. · Radiology
- Transpara 1.7.2ScreenPoint Medical B.V. · Radiology
- ProstatIDScanMed, LLC · Radiology
- Saige-DxDeepHealth, Inc. · Radiology
- BU-CADTaiHao Medical Inc. · Radiology
- MammoScreen 2.0Therapixel · Radiology
- Lunit INSIGHT MMGLunit Inc. · Radiology
- Transpara 1.7.0ScreenPoint Medical B.V. · Radiology
- ProFound AI Software V3.0iCAD Inc. · Radiology
- Genius AI DetectionHologic, Inc. · Radiology
- MammoScreenTherapixel · Radiology
- TransparaScreenPoint Medical B.V. · Radiology
- TransparaScreenpoint Medical B.V. · Radiology
- ProFound AI Software V2.1iCAD Inc. · Radiology
- PowerLook Tomo Detection V2 SoftwareiCAD Inc. · Radiology
- TransparaScreenPoint Medical BV · Radiology