De Novo · Granted
GrantedArteraAI Prostate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Artera, Inc. · SFH Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis
Granted on Jul 31, 2025 as a new device type through De Novo after a 248-day review.
- Decided
- Jul 31, 2025
- Review
- 248 days
- Class
- Class II
- Product code
- SFH
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 SFH? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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.
How does its category compare?
All SFH devicesSFH Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SFH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SFH
Too few SFH 510(k)s in any year since 2007 to give a median.
Recalls per year · SFH
No recall names SFH since 2007.
Adverse event reports per year · SFH
No MAUDE report names SFH 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 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ArteraAI Prostate is a software only device intended to analyze scanned histopathology whole slide images (WSIs) from treatment-naïve prostate core needle biopsies prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. ArteraAI Prostate provides 10-year risks of distant metastasis and prostate cancer specific mortality and is intended to assist physicians with prognostic risk-based decisions along…
Read the full statement (151 words)
ArteraAI Prostate is a software only device intended to analyze scanned histopathology whole slide images (WSIs) from treatment-naïve prostate core needle biopsies prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains.
ArteraAI Prostate provides 10-year risks of distant metastasis and prostate cancer specific mortality and is intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors in non-metastatic prostate cancer patients.
ArteraAI Prostate is intended for males 55 years of age or older without clinically or pathologically defined metastases, and who are candidates for curative intent management (surgery, radiation therapy with or without systemic therapy, or active surveillance).
ArteraAI Prostate is intended to utilize WSIs acquired from an FDA-cleared interoperable scanner with which ArteraAI Prostate has been authorized for use or a 510(k)-cleared scanner that has been assessed in accordance with the Predetermined Change Control Plan (PCCP) for qualifying additional interoperable scanners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240068 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240068: ArteraAI Prostate.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240068
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026