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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 the device name listed in this FDA 510(k) record. The listed applicant is Radlink, Inc.. It received FDA 510(k) clearance on 2025-03-18 under 510(k) 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. The listed applicant is Radlink, Inc.. The 510(k) number is K242161.

When did Radlink GPS Pro Imaging receive FDA 510(k) clearance?

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

Who is the listed applicant for Radlink GPS Pro Imaging?

The FDA 510(k) record lists Radlink, Inc. as the applicant. This does not by itself establish the device manufacturer.

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)

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.

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Official Source

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

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