QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM— 510(k) K892711

Substantially Equivalent

Quantitative Cardiac Systems (Qcs), Inc.

FDA 510(k) clearance K892711 for QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM, Substantially Equivalent on 1989-12-14. Applicant: Quantitative Cardiac Systems (Qcs), Inc..

Clearance details

Applicant: Quantitative Cardiac Systems (Qcs), Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1989-04-14
Decision date: 1989-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.