Genius AI Detection 2.0

K221449

Hologic, Inc. · cleared 2022-10-06 · product code QDQ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“Genius AI 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.”
Algorithmdeep learning networks, Convolutional Neural Network (CNN) model
source quote (p.4)
“Genius Al Detection analyzes each standard mammographic view in a digital breast tomosynthesis examination using deep learning networks. For each detected lesion, Genius Al The second change in Genius Al Detection 2.0 is the adoption of a more sophisticated Convolutional Neural Network (CNN) model for the key processing step of calcification cluster classification, replacing the previously used, simpler conventional Artificial Neural Network (ANN) model.”
Adaptive (vs locked)No
source quote (p.8)
“Algorithm enhancements as well as the expanded training data set were used during development of the 2.0 version. These changes do not raise any issues of safety and effectiveness.”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=764 cases

endpoints: detection sensitivity; specificity; rate of false positive marks per view

standards: ISO IEC 62304: 2015 – Medical device software – Software Life Cycle Processes (#13-79), ISO 14971: 2012 – Medical devices – Application of Risk Management to Medical Devices, DEN180005 Evaluation of automatic class III designation for OsteoDetect – Decision summary with special controls.

Reported performance (1 observation)

specificityas written: “specificity increase compared to predicate”0.12CI McNemar's p< 0.001
source quote (p.9)
“The specificity measured at the operating point of Genius AI Detection 2.0 demonstrated significant increase of 12% as compared to the original Genius AI Detection predicate device (McNemar's p< 0.001), while maintaining the sensitivity.”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
drift signals on this device
  • 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

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K221449