QCA PLUS— 510(k) K915542

Substantially Equivalent

Sanders Data Systems, LLC

FDA 510(k) clearance K915542 for QCA PLUS, Substantially Equivalent on 1992-01-24. Applicant: Sanders Data Systems, LLC.

Clearance details

Applicant: Sanders Data Systems, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 1991-12-10
Decision date: 1992-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, 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.