# K100094: Carestream Image Suite

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Heatlh, Inc.
- Decided: Mar 11, 2010 after 57 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954678 (1996). 9 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083673: Carestream Pacs, Model Carestream Pacs Vii, Carestream Health, Inc. (2008) Summary page 1.
- K060137: Kodak Eclipse Image Processing Software, Eastman Kodak Company (2006) Summary page 1.

## Most influential descendants
- K140271: Tablet Viewer Software for Image Suite (2014), 1 descendant of its own
- K251168: Image Suite (2025), 0 descendants of its own

## Recalls of this device
- Apr 15, 2016 · Class II · Z-1594-2016: Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)".
- Apr 15, 2016 · Class II · Z-1593-2016: Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)".

## Indications for use
CARESTREAM Image Suite is an image management system whose intended use is to receive, process, review, display, print and archive images and data from all imaging modalities. This excludes mammography applications in the United States.

Source page: https://510kreport.com/device/K100094
Methodology: https://510kreport.com/methodology