510(k) · Cleared
ClearedPowerLook Tomo Detection V2 Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icad, Inc. · QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Cleared on Dec 6, 2018 as substantially equivalent to DEN180005 (Imagen Technologies, Inc., 2018) after a 97-day review. Its family tree reaches back 1 generation to 2018. 7 later devices descend from it.
- Decided
- Dec 6, 2018
- Review
- 97 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180005 (2018). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- This deviceK182373 PowerLook Tomo Detection V2 SoftwareIcad, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK201019 Genius AI DetectionHologic, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK221449 Genius AI Detection 2.0Hologic, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK191994 ProFound AI Software V2.1Icad, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK203822 ProFound AI Software V3.0Icad, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK243341 Genius AI Detection 2.0Hologic, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K201019Genius AI DetectionHologic, Inc. · 2020 · cites it directly3descendants
- K221449Genius AI Detection 2.0Hologic, Inc. · 2022 · 2 generations on2descendants
- K191994ProFound AI Software V2.1Icad, Inc. · 2019 · cites it directly2descendants
- K203822ProFound AI Software V3.0Icad, Inc. · 2021 · 2 generations on1descendant
- K243341Genius AI Detection 2.0Hologic, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| 0 (this device) | K182373 | PowerLook Tomo Detection V2 Software | Icad, Inc. | 2018 | — |
| +1 | K201019 | Genius AI Detection | Hologic, Inc. | 2020 | — |
| +2 | K221449 | Genius AI Detection 2.0 | Hologic, Inc. | 2022 | — |
| +1 | K191994 | ProFound AI Software V2.1 | Icad, Inc. | 2019 | — |
| +2 | K203822 | ProFound AI Software V3.0 | Icad, Inc. | 2021 | — |
| +3 | K243341 | Genius AI Detection 2.0 | Hologic, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | DEN180005 | OsteoDetectSummary page 5…Decision Date Reference # OsteoDetect Imagen DEN180005 May 24, 2018 Device Description PLTD V2 detects malignant soft-tissue densities and calcifications in digital brea… | 2018 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2018, 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?
PowerLook® Tomo Detection V2 Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT systems. The system detects soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in the 3D DBT slices. The detections and Certainty of Finding and Case Scores assist interpreting physicians in identifying soft tissue densities and calcifications that may be confirmed or dismissed by the interpreting physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182373 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182373: PowerLook Tomo Detection V2 Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182373
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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