Cleared Traditional

Genius AI Detection 2.0

K243341 · Hologic, Inc. · Radiology

Jul 2025

Decision

279d

Days

Class 2

Risk

About This 510(k) Submission

K243341 is an FDA 510(k) clearance for the Genius AI Detection 2.0, a Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer (Class II — Special Controls, product code QDQ), submitted by Hologic, Inc. (Newark, US). The FDA issued a Cleared decision on July 31, 2025, 279 days after receiving the submission on October 25, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2090.

Submission Details

510(k) Number	K243341 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 25, 2024
Decision Date	July 31, 2025
Days to Decision	279 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	QDQ — Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2090
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.