510(k) · Cleared
ClearedGenius AI Detection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Cleared on Nov 18, 2020 as substantially equivalent to K182373 (Icad, Inc., 2018) after a 215-day review. Its family tree reaches back 2 generations to 2018. 3 later devices descend from it.
- Decided
- Nov 18, 2020
- Review
- 215 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180005 (2018). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 1 generation backK182373 PowerLook Tomo Detection V2 SoftwareIcad, Inc. · 2018
- This deviceK201019 Genius AI DetectionHologic, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK221449 Genius AI Detection 2.0Hologic, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK243341 Genius AI Detection 2.0Hologic, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK230096 Genius AI Detection 2.0 with CC-MLO CorrelationHologic, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −1 | K182373 | PowerLook Tomo Detection V2 Software | Icad, Inc. | 2018 | — |
| 0 (this device) | K201019 | Genius AI Detection | Hologic, Inc. | 2020 | — |
| +1 | K221449 | Genius AI Detection 2.0 | Hologic, Inc. | 2022 | — |
| +2 | K243341 | Genius AI Detection 2.0 | Hologic, Inc. | 2025 | — |
| +2 | K230096 | Genius AI Detection 2.0 with CC-MLO Correlation | Hologic, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QDQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QDQ device
- #1 K241831 Transpara (2.1.0)score 15.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182373 | PowerLook Tomo Detection V2 SoftwareSummary page 4…vice Class: Class II Review Panel: Radiology Submitter/510(k) Holder: iCAD Clearance: K182373 (cleared December 6, 2018) Device Description: Genius AI Detection is a software device intended to identify potential abnormali… | 2018 |
| † | DEN180005 | OsteoDetect | 2018 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221449 | Genius AI Detection 2.0 | 2022 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K221449 (Hologic, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K182373.
How does its category compare?
All QDQ devicesQDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QDQ
10so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QDQ
216in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QDQ
No recall names QDQ since 2007.
Adverse event reports per year · QDQ
No MAUDE report names QDQ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 3 | 173 | 0 | 0 |
| 2021 | 5 | 169 | 0 | 0 |
| 2022 | 4 | 131 | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 7 | 153 | 0 | 0 |
| 2025 | 5 | 216 | 0 | 0 |
| 2026 | 10 | 154 | 0 | — |
What is it indicated for?
Genius Al Detection is a computer-aided detection and diagnosis (CADe/CADXx) 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201019 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201019: Genius AI Detection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201019
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026