510(k) · Cleared
ClearedProFound AI Software V2.1
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 Oct 4, 2019 as substantially equivalent to K182373 (Icad, Inc., 2018) after a 70-day review. Its family tree reaches back 2 generations to 2018. 2 later devices descend from it.
- Decided
- Oct 4, 2019
- Review
- 70 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180005 (2018). 2 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 deviceK191994 ProFound AI Software V2.1Icad, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK203822 ProFound AI Software V3.0Icad, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK240417 ProFound Detection (V4.0)Icad, Inc. · 2024
Most influential descendants
Showing 2 of 2 · 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) | K191994 | ProFound AI Software V2.1 | Icad, Inc. | 2019 | — |
| +1 | K203822 | ProFound AI Software V3.0 | Icad, Inc. | 2021 | — |
| +2 | K240417 | ProFound Detection (V4.0) | Icad, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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…Computer Assisted Detection and Diagnosis Software Product Code: QDQ Regulation Number: 21 CFR 892.2090 Review Panel: Predicate Device: 510k Number: K182373 Manufacturer: iCAD, Inc. Device Name: ProFound™ AI V2 (PowerLook® Tomo Detection V2 Software Device Description… | 2018 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203822 | ProFound AI Software V3.0 | 2021 | 1 |
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 1 year and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K203822 (Icad, Inc., 2021) has gone furthest, with 1 descendant 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. 2019, 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?
ProFound™ AI V2.1 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/K191994 · printed Nov 4, 2026
Cite this page
510(k) Report. “K191994: ProFound AI Software V2.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K191994
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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