Cleared Traditional

Genius AI Detection 2.0

K221449 · Hologic, Inc. · Radiology

Oct 2022

Decision

141d

Days

Class 2

Risk

About This 510(k) Submission

K221449 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. (Marlborough, US). The FDA issued a Cleared decision on October 6, 2022, 141 days after receiving the submission on May 18, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2090.

Submission Details

510(k) Number	K221449 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 2022
Decision Date	October 06, 2022
Days to Decision	141 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.