SFH
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Pathology Software Algorithm Device Analyzing Digital Images For Cancer Prognosis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.3755
- Medical specialty
- Pathology
- FDA definition
- A pathology software algorithm device analyzing digital images for cancer prognosis is a software intended to analyze scanned whole slide images (WSIs) from prostate biopsies prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis.
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| Record | Firm | Date |
|---|---|---|
| ArteraAI Prostate (DEN240068) | Artera, Inc. | 2025-07-31 |
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