UC-CARE NAVIGO SYTEM— 510(k) K100784

Substantially Equivalent

UC-CARE , Ltd.

FDA 510(k) clearance K100784 for UC-CARE NAVIGO SYTEM, Substantially Equivalent on 2011-11-01. Applicant: UC-CARE , Ltd..

Clearance details

Applicant: UC-CARE , Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2010-03-19
Decision date: 2011-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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.