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FyreLink

by Mpacs, LLC

510(k) K030242

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030242 Date10 Mar 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

FyreLink is a picture archiving and communications system (PACS) used in radiology. It is a Class II medical device designed for integrating components in a network configuration, enabling the image acquisition unit to move patient studies directly to a server.

FyreLink received FDA 510(k) clearance under K030242 in 2003 as a substantially equivalent device. It is manufactured by Mpacs, LLC and supplied as a network solution for radiology imaging workflows.

Other devices from Mpacs, LLC

  • Fyrelink Vl

    Class II

  • Echolink

    Class II

Questions

AI-generated answers, 22 Sep 2026

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

  • What is FyreLink used for in a radiology setting?

    FyreLink is a picture archiving and communications system (PACS) designed to integrate components in a network configuration, allowing image acquisition units to transfer patient studies directly to a server, streamlining radiology imaging workflows.

  • How is FyreLink supplied and deployed in a healthcare facility?

    FyreLink is supplied as a network solution for radiology imaging workflows, meaning it is installed and configured within a facility’s existing network infrastructure to connect imaging devices to a central server for study storage and retrieval.

  • Is FyreLink a single-use or reusable medical device?

    FyreLink is a reusable software-based system; as a PACS platform, it is not consumed or discarded after use but is instead operated continuously over time to manage and store medical images within a radiology department.

  • What regulatory pathway was used for FyreLink’s market authorization?

    FyreLink received FDA 510(k) clearance under submission K030242 in 2003, demonstrating it was substantially equivalent to a legally marketed predicate device, which is the standard regulatory route for Class II medical devices like this PACS system.