510(k) · Cleared
ClearedMammoSightAI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurocareai, Inc. (Dba Savelife.Ai) · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on May 4, 2026 as substantially equivalent to K203517 (DeepHealth, Inc., 2021) after a 230-day review. Its family tree reaches back 3 generations to 2018.
- Decided
- May 4, 2026
- Review
- 230 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170073 (2018). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K203517 | Saige-QSummary page 5…te Device: Manufacturer Device Name Product Code Application Number DeepHealth Inc. Saige-Q QFM K203517 510(k) Summary Page 1 of 9 NEUROCAREAI IN… | 2021 |
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 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 3 ancestors has a recall.
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. 2026, 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?
MammoSightAI is a software radiological workflow tool designed to assist radiologists in prioritizing exams within the standard-of-care image worklist for compatible FFDM and DBT screening mammograms. Utilizing an advanced artificial intelligence algorithm, MammoSightAI analyzes each mammogram and assigns a tag indicating the software’s suspicion of at least one potentially suspicious finding. These assigned tags are seamlessly integrated into the…
Read the full statement (141 words)
MammoSightAI is a software radiological workflow tool designed to assist radiologists in prioritizing exams within the standard-of-care image worklist for compatible FFDM and DBT screening mammograms. Utilizing an advanced artificial intelligence algorithm, MammoSightAI analyzes each mammogram and assigns a tag indicating the software’s suspicion of at least one potentially suspicious finding. These assigned tags are seamlessly integrated into the hospital PACS or workstation, enabling worklist prioritization or triage to help radiologists focus on the most critical cases first.
MammoSightAI 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 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 as stated in the FDA summary.
https://510kreport.com/device/K252954 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252954: MammoSightAI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252954
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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