510(k) · Cleared
ClearedProFound AI Software V3.0
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 Mar 12, 2021 as substantially equivalent to K191994 (Icad, Inc., 2019) after a 73-day review. Its family tree reaches back 3 generations to 2018. 1 later device descends from it.
- Decided
- Mar 12, 2021
- Review
- 73 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN180005 (2018). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 2 generations backK182373 PowerLook Tomo Detection V2 SoftwareIcad, Inc. · 2018
- 1 generation backK191994 ProFound AI Software V2.1Icad, Inc. · 2019
- This deviceK203822 ProFound AI Software V3.0Icad, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK240417 ProFound Detection (V4.0)Icad, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240417ProFound Detection (V4.0)Icad, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −2 | K182373 | PowerLook Tomo Detection V2 Software | Icad, Inc. | 2018 | — |
| −1 | K191994 | ProFound AI Software V2.1 | Icad, Inc. | 2019 | — |
| 0 (this device) | K203822 | ProFound AI Software V3.0 | Icad, Inc. | 2021 | — |
| +1 | K240417 | ProFound Detection (V4.0) | Icad, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K191994 | ProFound AI Software V2.1Summary page 4…Detection and Diagnosis Software Product Code: QDQ Regulation Number: 21 CFR 892.2090 Review Panel: Radiology Predicate Device: 510k Number: K191994 Manufacturer: iCAD, Inc. Device Name: ProFound AI® V2.1 Device Description The ProFound AI® V3.0 device detects… | 2019 |
| † | K182373 | PowerLook Tomo Detection V2 Software | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240417 | ProFound Detection (V4.0) | 2024 | 0 |
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 3 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K240417 (Icad, Inc., 2024) has gone furthest, with 0 descendants of its own.
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. 2021, 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® V3.0 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203822 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203822: ProFound AI Software V3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203822
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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