510(k) K250664— Navigo Workstation 2.3 (FPRMC00039)

Substantially Equivalent

UC-CARE , Ltd.

Clearance details

Applicant: UC-CARE , Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2025-03-05
Decision date: 2025-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

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.