SHWClass II

Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis

21 CFR 864.3755 / Pathology

SHW is the FDA product code for Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis, a class II device type, regulated under 21 CFR 864.3755. FDA's definition for this code reads: "A pathology software algorithm device analyzing digital images for cancer prognosis is a software intended to analyze scanned whole slide images (WSIs) from breast cancer specimens prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. The device provides...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2026-05-04, and no recalls.

Classification record

Product code: SHW
Device name: Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
FDA 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.
Regulation: 21 CFR 864.3755
Device class: Class II
Review panel: Pathology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 2
Ingested recalls: 0

Clearances, product code SHW

By decision year

2 clearances under product code SHW with a decision year between 2026 and 2026, 2026 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code SHW by decision year
Year	Clearances
2026	2

Applicants with the most clearances

Product code SHW

Applicants holding the most 510(k) clearances under product code SHW
Applicant	Clearances
Artera	1
SimBioSys, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code SHW.

Recent clearances

Product code SHW

Recent recalls

Product code SHW

FDA records show no recalls under product code SHW.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)