Cleared Traditional

Genius AI Detection 2.0 with CC-MLO Correlation

K230096 · Hologic, Inc. · Radiology

May 2023

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K230096 is an FDA 510(k) clearance for the Genius AI Detection 2.0 with CC-MLO Correlation, a Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer (Class II — Special Controls, product code QDQ), submitted by Hologic, Inc. (Marlborough, US). The FDA issued a Cleared decision on May 23, 2023, 130 days after receiving the submission on January 13, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2090.

Submission Details

510(k) Number	K230096 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 2023
Decision Date	May 23, 2023
Days to Decision	130 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.