Genius AI Detection 2.0 with CC-MLO Correlation

K230096

Hologic, Inc. · cleared 2023-05-23 · 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
source quote (p.5)
“Genius AI Detection analyzes each standard mammographic view in a digital breast tomosynthesis examination using deep learning networks.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.6)
“"Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued on October 2, 2014.”

Validation studies (1)

Standalone

n=667 cases

endpoints: accuracy of the CC-MLO Correlation feature

standards: 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)

accuracyas written: “accuracy of the CC-MLO Correlation feature”stated without value
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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
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

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/K230096