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

Name: FDA 510(k) clearance K250664
Creator: U.S. Food and Drug Administration
Published: 2025-08-07

Substantially Equivalent

UC-CARE , Ltd.

FDA 510(k) clearance K250664 for Navigo Workstation 2.3 (FPRMC00039), Substantially Equivalent on 2025-08-07. Applicant: UC-CARE , Ltd.. Device class: 2.

Clearance details

Applicant: UC-CARE , Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-03-05
Decision date: 2025-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from UC-CARE , Ltd.

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K260161 — SmartGuide Disposable Guides and Grids2026-07-30
K173054 — Navigo Workstation Version 2.02018-01-16
K160934 — UC-CARE NaviGo Workstation2017-02-06
K100784 — UC-CARE NAVIGO SYTEM2011-11-01
K090978 — UC-CARE WARMING SYSTEM2009-08-10

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.