Genius AI Detection
K201019Hologic, Inc. · cleared 2020-11-18 · product code QDQ · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“Genius Al Detection is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthesis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in DBT exams from compatible DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score. The device intends to aid in the interpretation of digital breast tomosynthesis exams in a concurrent fashion, where the interpreting physician confirms or dismisses the findings during the reading of the exam.”
source quote (p.4)
“Genius Al Detection analyzes each standard mammographic view in a digital breast tomosynthesis examination using deep learning networks.”
source quote (p.5)
“"Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” issued on October 2, 2014”
Validation studies (2)
Reader study (MRMC)
n=390 cases
endpoints: AUC; sensitivity; recall rate for non-cancer cases; case read-time
Standalone
n=764 cases
endpoints: detection performance; number and type of cancers detected; fROC analysis
Reported performance (3 observations)
source quote (p.10)
“The average observed reader sensitivity for cancer cases was 75.9% with CAD and 66.8% without CAD.”
source quote (p.9)
“The average observed AUC was 0.825 (95% CI: 0.783, 0.867) with CAD and 0.794 (95% CI: 0.748, 0.840) without CAD.”
source quote (p.10)
“The average observed recall rate for non-cancer cases was 25.8% with CAD and 23.4% without CAD.”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K230096 (decision 2023-05-23) from Hologic, Inc. for a matching device line ("Genius AI Detection 2.0 with CC-MLO Correlation") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K230096
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K221449 (decision 2022-10-06) 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:K221449
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).