510(k) · Cleared
ClearedSaige-Q
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DeepHealth, Inc. · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Apr 16, 2021 as substantially equivalent to K183285 (Curemetrix, Inc., 2019) after a 137-day review. Its family tree reaches back 2 generations to 2018. 1 later device descends from it.
- Decided
- Apr 16, 2021
- Review
- 137 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN170073 (2018). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K252954MammoSightAINeurocareai, Inc. (Dba Savelife.Ai) · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −1 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| 0 (this device) | K203517 | Saige-Q | DeepHealth, Inc. | 2021 | — |
| +1 | K252954 | MammoSightAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 QFM? 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 QFM device
- #1 K211733 Lunit INSIGHT CXR Triagescore 21.2 · 4 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 |
|---|---|---|---|
| * | K183285 | cmTriageSummary page 4…ological Computer-Assisted Triage and Notification Software Regulatory Class: Class II (21 CFR 892.2080) Product Code: QFM Predicate Devices CureMetrix, Inc., cmTriage, K183285 Device Description Saige-Q is a software workflow device that processes Digital Breast Tomosynthesis (DBT) and Ful… | 2019 |
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 |
|---|---|---|---|
| K252954 | MammoSightAI | 2026 | 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 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K252954 (Neurocareai, Inc. (Dba Savelife.Ai), 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K183285.
How does its category compare?
All QFM devicesQFM Radiological Computer-Assisted Prioritization Software For Lesions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QFM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFM
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QFM
No recall names QFM since 2007.
Adverse event reports per year · QFM
No MAUDE report names QFM 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 | 0 | — | 0 | 0 |
| 2019 | 4 | 97 | 0 | 0 |
| 2020 | 4 | 172 | 0 | 0 |
| 2021 | 5 | 187 | 0 | 0 |
| 2022 | 9 | 121 | 0 | 0 |
| 2023 | 8 | 206 | 0 | 0 |
| 2024 | 6 | 192 | 0 | 0 |
| 2025 | 3 | 100 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Saige-Q is a software workflow tool designed to aid radiologists in prioritizing exams within the standard-of-care image worklist for compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) screening mammograms. Saige-Q uses an artificial intelligence algorithm to generate a code for a given mammogram, indicative of the software’s suspicion that the mammogram contains at least one suspicious finding. Saige-Q makes the…
Read the full statement (155 words)
Saige-Q is a software workflow tool designed to aid radiologists in prioritizing exams within the standard-of-care image worklist for compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) screening mammograms. Saige-Q uses an artificial intelligence algorithm to generate a code for a given mammogram, indicative of the software’s suspicion that the mammogram contains at least one suspicious finding. Saige-Q makes the assigned codes available to a PACS/EPR/RIS/workstation for worklist prioritization or triage.
Saige-Q is intended for passive notification only and does not provide any diagnostic information beyond triage and prioritization. Thus, it is not intended to replace the review of images or be used on a stand-alone basis for clinical decision-making. The decision to use Saige-Q codes and how to use those codes is ultimately up to the interpreting radiologist. The interpreting radiologist is responsible for reviewing each exam on a diagnostic viewer and evaluating each patient according to the current standard of care.
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/K203517 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203517: Saige-Q.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203517
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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