Genius AI Detection 2.0
FDA 510(k) K243341 · Hologic, Inc.
Submission
- Device name
- Genius AI Detection 2.0
- Applicant
- Hologic, Inc.
Newark, DE, US - Received
- October 25, 2024
- Decision date
- July 31, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QDQ – Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2090
- Specialty
- Radiology
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…
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Questions and answers
When was Genius AI Detection 2.0 cleared by the FDA?
Genius AI Detection 2.0 (K243341) received a 510(k) decision of Substantially Equivalent on July 31, 2025, 279 days after the submission was received.
What is the product code of K243341?
The FDA product code is QDQ – Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, a Class II (moderate risk) device regulated under 21 CFR 892.2090.