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Radlink GPS

by Radlink, Inc.

510(k) K142718

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142718 Date17 Dec 2014ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MQB
Device class
Class II
Regulation
21 CFR Part 892.1680
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Radlink GPS is a Solid State X-Ray Imager (Flat Panel/Digital Imager), a type of digital radiography detector designed to capture high-resolution radiographic images for diagnostic purposes. It employs a flat-panel detector technology to convert X-ray exposure into digital signals, enabling real-time imaging and improved visualization of anatomical structures. This device is classified under Class II medical devices, indicating moderate regulatory oversight due to its role in critical diagnostic imaging.

The Radlink GPS is intended for use in radiology departments within healthcare settings, where it is integrated into X-ray systems to produce digital radiographic images. Supplied as a reusable device, it requires proper cleaning, disinfection, and maintenance to ensure sterility and functionality. The imager operates within standard MRI-safe environments, adhering to safety guidelines for electromagnetic interference. Authorized under FDA 510K clearance (K142718), it is regulated under the Federal Food, Drug, and Cosmetic Act (21 CFR 892.1680) and falls under the Radiology advisory committee classification.

Similar devices

Other devices filed under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)).

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