510(k) Report

FDA applicant

Quantitative Insights, Inc.

Chicago, IL2 decisions2017–20170 recalls

FDA records 2 decisions for Quantitative Insights, Inc. (Chicago, IL) in 2017: 1 510(k) clearance and 1 De Novo grant. Most are in product codes POK (Computer-Assisted Diagnostic Software For…) and LLZ (System, Image Processing, Radiological). Its devices cite 2 predicates, 0 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 Quantitative Insights, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2017

2017: 2
2017high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Quantitative Insights, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • POKComputer-Assisted Diagnostic Software For Lesions Suspicious For Cancer1decision
  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN170022QuantXQuantitative Insights, Inc. · 20174cite it
  • K170195QuantXQuantitative Insights, Inc. · 20171cites it

What has FDA decided for it lately?

  • DEN170022QuantXQuantitative Insights, Inc. · 2017
  • K170195QuantXQuantitative Insights, Inc. · 2017

All 2 as Quantitative Insights, Inc. →

Other applicant names beginning “Quantitative”

FDA records each applicant name separately; these may or may not be the same firm.

Quantitative Medicine, Inc. 8Quantitative Technologies, Inc. 2Quantitative 1Quantitative Cardiac Systems (Qcs), Inc. 1Quantitative Radiology Solutions, LLC 1