# K023246: Amalga Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Global Care Solutions, S.A.
- Decided: Dec 23, 2002 after 84 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010259 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010259: Mediface Pacs, Mediface Co., Ltd. (2001)

## Indications for use
AMALGA PACS is a device that receives medical images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, FUF Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K023246
Methodology: https://510kreport.com/methodology