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 May 12, 2022 as substantially equivalent to K181704 (Screenpoint Medical B.V., 2018) after a 120-day review. Its family tree reaches back 2 generations to 2018. 4 later devices descend from it.
- Decided
- May 12, 2022
- Review
- 120 days
- Class
- Class II
- Product code
- QDQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180005 (2018). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 1 generation backK181704 TransparaScreenpoint Medical B.V. · 2018
- This deviceK220105 Saige-DxDeepHealth, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK241747 Saige-DxDeepHealth, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK243688 Saige-Dx (3.1.0)DeepHealth, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK251873 Saige-DxDeepHealth, Inc. · 2025
- Descendant · 4 generations on · 0 of its ownK253825 Saige-DxDeepHealth, Inc. · 2026
Most influential descendants
Showing 4 of 4 · 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 | K181704 | Transpara | Screenpoint Medical B.V. | 2018 | — |
| 0 (this device) | K220105 | Saige-Dx | DeepHealth, Inc. | 2022 | — |
| +1 | K241747 | Saige-Dx | DeepHealth, Inc. | 2024 | — |
| +2 | K243688 | Saige-Dx (3.1.0) | DeepHealth, Inc. | 2024 | — |
| +3 | K251873 | Saige-Dx | DeepHealth, Inc. | 2025 | — |
| +4 | K253825 | Saige-Dx | DeepHealth, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K181704 | TransparaSummary page 4…Software Regulation Name and Number: Radiological Computer Assisted Detection and Diagnosis Software (21 CFR 892.2090) Regulation Class: 11 Product Code: QDQ 510(K) No.: K181704 DeepHealth 1000 Massac… | 2018 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241747 | Saige-Dx | 2024 | 3 |
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 4 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K241747 (DeepHealth, Inc., 2024) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K181704.
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. 2022, 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 manmogram, 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/K220105 · printed Nov 3, 2026
Cite this page
510(k) Report. “K220105: Saige-Dx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K220105
Report an extraction error
Are you the manufacturer?
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