# K060055: Kodak Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: Feb 7, 2006 after 29 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K063267: Isite Pacs, V 4. X (2006), 8 descendants of its own
- K111804: Intellispace Pacs 4.X (2011), 5 descendants of its own
- K160315: I4 (Integrated Intelligent Imaging Informatics) system (2016), 3 descendants of its own
- K173588: Illumeo System (2018), 2 descendants of its own
- K250181: AV Viewer (2025), 1 descendant of its own

## Indications for use
The KODAK PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive/distribute/retrieve and display images and data from all hospital modalities and information systems. This includes the display of structured reports from CAD systems with DICOM "for presentation" mammography images.

Source page: https://510kreport.com/device/K060055
Methodology: https://510kreport.com/methodology