510(k) Report

FDA applicant

SimBioSys, Inc.

Chicago, IL4 decisions2023–20260 recalls

FDA records 4 decisions for SimBioSys, Inc. (Chicago, IL) from 2023 to 2026: 4 510(k) clearances. Most are in product codes QIH (Automated Radiological Image Processing Software) and SHW (Pathology Software Algorithm Device Analyzing…). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided SimBioSys, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023: 12024: 12025: 12026 (partial year): 1
2023high 1 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — SimBioSys, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • QIHAutomated Radiological Image Processing Software3decisions
  • SHWPathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 29 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 150 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K243189TumorSight VizSimBioSys, Inc. · 20241cites it
  • K231130TumorSight VizSimBioSys, Inc. · 20231cites it

What has FDA decided for it lately?

  • K260023TumorSight RiskSimBioSys, Inc. · 2026
  • K251766TumorSight VizSimBioSys, Inc. · 2025
  • K243189TumorSight VizSimBioSys, Inc. · 2024
  • K231130TumorSight VizSimBioSys, Inc. · 2023

All 4 as SimBioSys, Inc. →