510(k) Report

FDA applicant

Quantitative Cardiac Systems (Qcs), Inc.

Ann Arbor, MI1 decision1989–19890 recalls

FDA records 1 decision for Quantitative Cardiac Systems (Qcs), Inc. (Ann Arbor, MI) in 1989: 1 510(k) clearance. All are in product code LLZ (System, Image Processing, Radiological). 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 Cardiac Systems (Qcs), Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Quantitative Cardiac Systems (Qcs), Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Quantitative Cardiac Systems (Qcs), Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological1decision

What has FDA decided for it lately?

  • K892711Quantim 2000I Digital Image Analysis SystemQuantitative Cardiac Systems (Qcs), Inc. · 1989

The one decision as Quantitative Cardiac Systems (Qcs), 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 Insights, Inc. 2Quantitative 1Quantitative Radiology Solutions, LLC 1