Genius AI Detection 2.0 with CC-MLO Correlation
K230096Hologic, Inc. · cleared 2023-05-23 · product code QDQ · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Genius AI Detection is a software device intended to identify potential abnormalities in breast tomosynthesis images. Genius AI Detection 2.0 with CC-MLO Correlation is a software-only device.”
source quote (p.5)
“Genius AI Detection analyzes each standard mammographic view in a digital breast tomosynthesis examination using deep learning networks.”
source quote (p.6)
“"Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued on October 2, 2014.”
Validation studies (1)
Retrospective clinical
n=667 cases
endpoints: accuracy of the CC-MLO Correlation feature; safety and effectiveness in detecting soft tissue lesions and calcification lesions and correlating the CC-MLO findings
standards: IEC 62304: 2015, ISO 14971: 2012
Reported performance (1 observation)
source quote (p.11)
“The accuracy of the CC-MLO Correlation feature was estimated in both groups by scoring the detection pairs against the truth pairs and by evaluating the expert radiologist's response, respectively.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K243341 (decision 2025-07-31) from Hologic, Inc. for a matching device line ("Genius AI Detection 2.0") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243341
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).