# K030781: Kodak Directview Pacs/Image Management System, Kodak Directview Workflow Manager,Kodak Directview CX/DX, Kodak Directvib

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: May 29, 2003 after 79 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.
20 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) AccuRad: named in the summary without a submission number
- (no number) Archive Manager: named in the summary without a submission number

## Most influential descendants
- K042292: Isite Pacs (2004), 15 descendants of its own
- 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

## Indications for use
The Kodak Directview 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.

Source page: https://510kreport.com/device/K030781
Methodology: https://510kreport.com/methodology