510(k) · Cleared
ClearedSaige-Dx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DeepHealth, Inc. · QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Cleared on Jun 15, 2026 as substantially equivalent to K251873 (DeepHealth, Inc., 2025) after a 196-day review. Its family tree reaches back 6 generations to 2018.
- Decided
- Jun 15, 2026
- Review
- 196 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN180005 (2018). No later device cites it as a predicate yet.
- Root · 6 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 5 generations backK181704 TransparaScreenpoint Medical B.V. · 2018
- 4 generations backK220105 Saige-DxDeepHealth, Inc. · 2022
- 3 generations backK241747 Saige-DxDeepHealth, Inc. · 2024
- 2 generations backK243688 Saige-Dx (3.1.0)DeepHealth, Inc. · 2024
- 1 generation backK251873 Saige-DxDeepHealth, Inc. · 2025
- This deviceK253825 Saige-DxDeepHealth, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −5 | K181704 | Transpara | Screenpoint Medical B.V. | 2018 | — |
| −4 | K220105 | Saige-Dx | DeepHealth, Inc. | 2022 | — |
| −3 | K241747 | Saige-Dx | DeepHealth, Inc. | 2024 | — |
| −2 | K243688 | Saige-Dx (3.1.0) | DeepHealth, Inc. | 2024 | — |
| −1 | K251873 | Saige-Dx | DeepHealth, Inc. | 2025 | — |
| 0 (this device) | K253825 | Saige-Dx | DeepHealth, Inc. | 2026 | — |
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 |
|---|---|---|---|
| * | K251873 | Saige-DxSummary page 6…Names: Radiological Computer Assisted Detection/Diagnosis Software for Lesions Suspicious for Cancer (21 CFR 892.2090) Regulation Class: II Product Code: QDQ 510(K) No.: K251873 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. 4. DEVICE DES… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- None of the 6 ancestors has a recall.
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. 2026, 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?
Saige-Dx analyzes digital breast tomosynthesis (DBT) mammograms to identify the presence or absence of soft tissue lesions and calcifications that may be indicative of cancer. For a given DBT mammogram, Saige-Dx analyzes the DBT image stacks and the accompanying 2D images, including full field digital mammography and/or synthetic images. The system assigns a Suspicion Level, indicating the strength of suspicion that cancer may be present, for each detected finding and for the entire case. The outputs of Saige-Dx are intended to be used as a concurrent reading aid for interpreting physicians on screening mammograms with compatible DBT hardware.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253825 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253825: Saige-Dx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253825
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026