510(k) Report

FDA product code · Pathology

Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis

SHWClass II21 CFR 864.3755510(k) required2 decisions since 20260 recalls

2 FDA decisions since 2026. No recall names this code. The most-cited predicate is K254115, named by 1 later device.

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…

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, pathology panel

Twenty years of SHW at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · SHW

2so far in 2026, the most since 2007

2026 (partial year): 2
2007high 2 (2026) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SHW

Too few SHW 510(k)s in any year since 2007 to give a median.

Recalls per year · SHW

No recall names SHW since 2007.

Adverse event reports per year · SHW

No MAUDE report names SHW since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20262—0—
FIG. 1 — SHW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in SHW? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do SHW devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K254115ArteraAI BreastArtera, Inc. · 20261cites it

Which SHW devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K260023TumorSight RiskSimBioSys, Inc. · 20261generation

What has FDA decided in SHW lately?

  • K260023TumorSight RiskSimBioSys, Inc. · 2026
  • K254115ArteraAI BreastArtera, Inc. · 2026

All 2 SHW decisions →

Related product codes

Other codes under 21 CFR 864.3755.

SFH Pathology Software Algorithm Device Analyzing…