QDQ — Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer Class II

FDA Device Classification

Classification Details

Product Code
QDQ
Device Class
Class II
Regulation Number
892.2090
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Definition

A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251474median technologiesMedian LCS (internal name) / eyonis LCS (trade name) (1.0)February 6, 2026
K251873deephealthSaige-DxAugust 11, 2025
K243341hologicGenius AI Detection 2.0July 31, 2025
K243679therapixelMammoScreen® (4)July 3, 2025
K242683quibim s.lQP-Prostate® CADMarch 18, 2025
K241770siemens healthcareProstate MR AI (VA10A)March 5, 2025
K243688deephealthSaige-Dx (3.1.0)December 19, 2024
K241831screenpoint medicalTranspara (2.1.0)November 25, 2024
K241747deephealthSaige-DxNovember 18, 2024
K240417icadProFound Detection (V4.0)November 8, 2024
K242652lunitLunit INSIGHT DBT v1.1October 4, 2024
K240697see-mode technologies pteSee-Mode Augmented Reporting Tool, Thyroid (SMART-T)September 9, 2024
K240301therapixelMammoScreen® (3)August 1, 2024
K231470lunitLunit INSIGHT DBTNovember 6, 2023
K230096hologicGenius AI Detection 2.0 with CC-MLO CorrelationMay 23, 2023
K221449hologicGenius AI Detection 2.0October 6, 2022
K221347screenpoint medicalTranspara 1.7.2August 3, 2022
K212783scanmedProstatIDJuly 8, 2022
K220105deephealthSaige-DxMay 12, 2022
K210670taihao medicalBU-CADDecember 21, 2021