FDA product code SHW: Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
SHW is the FDA product code for pathology software algorithm device analyzing digital images for breast cancer prognosis. It is a Class II device, regulated under 21 CFR 864.3755 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under SHW, 1 in the last five years. The average 510(k) review took 136 days (median 136); 136 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis |
| Device class | Class II |
| Regulation | 21 CFR 864.3755 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) |
510(k) clearances per year for SHW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 136 |
Compare with all 510(k) review times · Search every SHW clearance
Top SHW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Artera, Inc. | 1 | 2026-05-04 |
Most recent SHW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254115 | Artera, Inc. | ArteraAI Breast | 2026-05-04 | 136 |
Recalls for SHW devices
openFDA lists no recalls for product code SHW.
Frequently asked questions
What is FDA product code SHW?
SHW is the FDA product code for pathology software algorithm device analyzing digital images for breast cancer prognosis. It is a Class II device, regulated under 21 CFR 864.3755 and reviewed by the Pathology panel.
What device class is SHW?
Class II, regulation 21 CFR 864.3755. Typical premarket route: 510(k).
How long does a 510(k) take for product code SHW?
Across 1 cleared submissions the average was 136 days from receipt to decision (median 136).
Which companies have the most SHW clearances?
Artera, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SHW
- Run a recall and safety report across every SHW manufacturer
- Watch product code SHW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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