Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Navigo Workstation 2.3 (FPRMC00039)

K-Number: K250664 · 2025-08-07

ApplicantUC-CARE , Ltd.
Decision Date2025-08-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Navigo Workstation 2.3 (FPRMC00039) is the device name listed in this FDA 510(k) record. The listed applicant is UC-CARE , Ltd.. It received FDA 510(k) clearance on 2025-08-07 under 510(k) number K250664. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Navigo Workstation 2.3 (FPRMC00039)?

Navigo Workstation 2.3 (FPRMC00039) is a medical device that received FDA 510(k) clearance on 2025-08-07. The listed applicant is UC-CARE , Ltd.. The 510(k) number is K250664.

When did Navigo Workstation 2.3 (FPRMC00039) receive FDA 510(k) clearance?

Navigo Workstation 2.3 (FPRMC00039) received FDA 510(k) clearance on 2025-08-07, under 510(k) number K250664.

Who is the listed applicant for Navigo Workstation 2.3 (FPRMC00039)?

The FDA 510(k) record lists UC-CARE , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Navigo Workstation 2.3 (FPRMC00039)?

The FDA product code for Navigo Workstation 2.3 (FPRMC00039) is LLZ.

Other records listing UC-CARE , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260161SmartGuide Disposable Guides and GridsK173054Navigo Workstation Version 2.0K160934UC-CARE NaviGo Workstation

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑