SHW — Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis Class II
FDA product code SHW covers "Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis", a Class II medical device regulated under 21 CFR 864.3755. Submissions are reviewed by the Pathology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SHW
- Device Class
- Class II
- Regulation Number
- 864.3755
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Pathology
- Implant
- No
Definition
A pathology software algorithm device analyzing digital images for breast cancer prognosis is a software intended to analyze digital images acquired from medical imaging devices (for example but not limited to - whole slide imaging scanners). 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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254115 | Artera | ArteraAI Breast | May 4, 2026 |