# K131392: Etiam Pacs Components

- Pathway: 510(k) (Traditional)
- Applicant: Etiam S.A.S.U.
- Decided: May 29, 2013 after 15 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: 6 generations back to K942120 (1994). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052358: Etiam Star Pacs Components, Etiam, S.A. (2005) Summary page 2.
- K062488: IQ-System Pacs System, Image Information Systems, Ltd. (2006) Summary page 2.
- K083618: Pacs Scan, Pacsgear, Inc. (2009) Summary page 2.

## Indications for use
ETIAM PACS Components TM is intended to be used by healthcare personnel to import, review, edit and send medical images. ETIAM PACS Components TM is not labeled for diagnostic use. ETIAM PACS Components TM is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.

Source page: https://510kreport.com/device/K131392
Methodology: https://510kreport.com/methodology