Devices · Therapixel

MammoScreen® (4)

Therapixel is listed for MammoScreen® (4) (K243679). The FDA list gives July 3, 2025 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QDQ as “Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer”: 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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243679

Official FDA database record

Date of final decision

July 3, 2025

Company on the FDA list

Therapixel

Lead panel

Radiology

Primary product code

QDQ

openFDA device name for the code

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

Device class

2

Regulation number

892.2090

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary