510(k) · Radiology

Genius AI Detection 2.0

by Hologic, Inc.

Genius AI Detection 2.0 is an AI-enabled medical device from Hologic, Inc. that the U.S. FDA cleared through 510(k) K243341 on July 31, 2025. Its lead review panel is Radiology and its primary product code is QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer).

See also FDA-cleared AI radiology devices in 2025, all FDA AI clearances in 2025, top radiology AI devices.

Key facts

Submission numberK243341
Pathway510(k)
Date of final decision
Company (FDA list)Hologic, Inc.
Lead review panelRadiology
Primary product codeQDQ — Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Applicant (openFDA)Hologic, Inc.
Applicant locationNewark, DE, US
Device classClass 2
Regulation number21 CFR 892.2090
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Genius AI Detection 2.0 went through this pathway (K243341).

openFDA lists it as a Class 2 device under 21 CFR 892.2090. Class II devices are moderate risk and are subject to general and special controls.

Product code QDQ covers 36 devices on the FDA AI list. By decision date, this device is #29 of 36 under that code. Hologic, Inc. has 9 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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