# K052358: Etiam Star Pacs Components

- Pathway: 510(k) (Traditional)
- Applicant: Etiam, S.A.
- Decided: Oct 5, 2005 after 37 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: 4 generations back to K942120 (1994). 7 ancestors in all.
56 later devices descend from it; 2 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042313: Integradweb MPR/Mip, Dynamic Imaging, Inc. (2004) Summary page 1.

## Most influential descendants
- K062488: IQ-System Pacs System (2006), 55 descendants of its own
- K063470: Aycan Workstation Osirix (2007), 49 descendants of its own
- K101342: Osirix MD (2010), 44 descendants of its own
- K143374: BLUEPRINT Patient Specific Instrumentation (2015), 31 descendants of its own
- K160555: BLUEPRINT Patient Specific Instrumentation (2016), 25 descendants of its own

## Indications for use
ETIAM STAR 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 offers at least 5 Mpixel resolution and 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/K052358
Methodology: https://510kreport.com/methodology