510(k) · Cleared
ClearedTumorSight Risk
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SimBioSys, Inc. · SHW Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
Cleared on Sep 25, 2026 as substantially equivalent to K254115 (Artera, Inc., 2026) after a 263-day review. Its family tree reaches back 1 generation to 2026.
- Decided
- Sep 25, 2026
- Review
- 263 days
- Class
- Class II
- Product code
- SHW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K254115 (2026). No later device cites it as a predicate yet.
- Root · 1 generation backK254115 ArteraAI BreastArtera, Inc. · 2026
- This deviceK260023 TumorSight RiskSimBioSys, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K254115 | ArteraAI Breast | Artera, Inc. | 2026 | — |
| 0 (this device) | K260023 | TumorSight Risk | SimBioSys, 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 SHW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K254115 | ArteraAI Breast Cleared while this submission was under review Summary page 5…is Regulation Number: 21 CFR §864.3755 Product Code: SHW Committee/Panel: Pathology Device Class: II Identification of the Legally Marketed Predicate Device Predicate: K254115 Predicate Trade Name: ArteraAI Breast Regulation Number: 21 CFR §864.3755 Product Code: SHW Committee/Panel: Pathology Intended… | 2026 |
| † | K251766 | TumorSight Viz | 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?
- Its one ancestor has no recall.
How does its category compare?
All SHW devicesSHW Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SHW
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SHW
Too few SHW 510(k)s in any year since 2007 to give a median.
Recalls per year · SHW
No recall names SHW since 2007.
Adverse event reports per year · SHW
No MAUDE report names SHW 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 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
TumorSight Risk is an artificial intelligence based software only device that analyzes data from previously diagnosed invasive breast cancer patients to assess the risk of recurrence. TumorSight Risk utilizes the following data: age, race, cancer stage, nodal status, and grade, combined with Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) data to generate 5- and 10-year risks of breast cancer recurrence and a proprietary prognostic score.…
Read the full statement (113 words)
TumorSight Risk is an artificial intelligence based software only device that analyzes data from previously diagnosed invasive breast cancer patients to assess the risk of recurrence. TumorSight Risk utilizes the following data: age, race, cancer stage, nodal status, and grade, combined with Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) data to generate 5- and 10-year risks of breast cancer recurrence and a proprietary prognostic score.
TumorSight Risk is intended for use in adult women with hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-), lymph node negative (N0) or positive (N1), Stage I-IIIA breast cancer to inform a physician in prognostic risk-based decisions in conjunction with other relevant clinicopathological factors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260023 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260023: TumorSight Risk.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260023
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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