# K062488: IQ-System Pacs System

- Pathway: 510(k) (Traditional)
- Applicant: Image Information Systems, Ltd.
- Decided: Sep 19, 2006 after 25 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: 5 generations back to K942120 (1994). 8 ancestors in all.
55 later devices descend from it; 5 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)
- K052358: Etiam Star Pacs Components, Etiam, S.A. (2005) Summary page 1.

## Most influential descendants
- 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
- K162800: BLUEPRINT Patient Specific Instrumentation (2017), 23 descendants of its own

## Indications for use
iQ-System PACS is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.

Source page: https://510kreport.com/device/K062488
Methodology: https://510kreport.com/methodology