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Amalga PACS

by Global Care Solutions, S.A.

510(k) K023246

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 NumberK023246 Date23 Dec 2002ClearedStatusActive

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  • Withdrawn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, 19 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 Amalga PACS is a Picture Archiving and Communication System (PACS) designed to receive, store, process, and transmit digital medical images and data from multiple imaging modalities, including CT scanners, MR scanners, ultrasound systems, radiographic devices, and secondary capture sources. It serves as a centralized platform for managing and distributing diagnostic imaging information within healthcare facilities.

Operated by trained clinical professionals, the Amalga PACS facilitates simultaneous multi-user access to patient imaging data across facility networks. Supplied as a traditional Class II device with FDA 510(k) clearance (K023246), it is intended for use in clinical environments where digital image management is required. The system does not specify single-use or reusable status, sterility, or MRI safety in its regulatory submission.

Questions

AI-generated answers, 19 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 types of medical imaging equipment can the Amalga PACS integrate with and manage?

    The Amalga PACS is designed to integrate with a wide range of imaging modalities, including CT scanners, MR scanners, ultrasound systems, radiographic devices, and secondary capture sources. This versatility allows it to serve as a centralized platform for receiving, storing, and transmitting digital medical images and data across these different systems within a healthcare facility.

  • How does the Amalga PACS support multi-user access in a clinical setting?

    The Amalga PACS is built to enable simultaneous multi-user access to patient imaging data across facility networks. This means multiple trained clinical professionals can view, analyze, and share diagnostic images and related data in real time, improving collaboration and workflow efficiency in clinical environments.

  • Is the Amalga PACS intended for use in specific regulatory or advisory categories?

    The Amalga PACS was reviewed by the FDA’s Radiology (RA) Advisory Committee under product code LLZ, which categorizes it as a traditional Class II device. Its regulatory submission indicates it is intended for use in clinical environments where digital image management is required, specifically for managing and distributing diagnostic imaging information.

  • How is the Amalga PACS supplied, and does it have any special handling requirements?

    The Amalga PACS is supplied as a traditional Class II device and is not described as single-use or reusable in its regulatory submission. Since it is a software-based system (PACS), it does not require sterility or physical handling precautions like medical devices that come into direct contact with patients. However, proper IT infrastructure, network security, and system maintenance are essential for optimal performance.