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

FDA 510(k)

Radlink GPS Pro Imaging

K-Number: K242161 · 2025-03-18

ApplicantRadlink, Inc.
Decision Date2025-03-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Radlink GPS Pro Imaging is a medical device manufactured by Radlink, Inc.. It received FDA 510(k) clearance on 2025-03-18 under approval number K242161. 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 Radlink GPS Pro Imaging?

Radlink GPS Pro Imaging is a medical device that received FDA 510(k) clearance on 2025-03-18. It is manufactured by Radlink, Inc.. The 510(k) number is K242161.

When was Radlink GPS Pro Imaging approved by the FDA?

Radlink GPS Pro Imaging received FDA 510(k) clearance on 2025-03-18, under approval number K242161.

What company makes Radlink GPS Pro Imaging?

Radlink GPS Pro Imaging is manufactured by Radlink, Inc..

What is the FDA product code for Radlink GPS Pro Imaging?

The FDA product code for Radlink GPS Pro Imaging is LLZ.

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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.

↑