# K180809: Eclipse II

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Jun 21, 2018 after 85 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K060137 (2006). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060137: Kodak Eclipse Image Processing Software, Eastman Kodak Company (2006) Summary page 4.

## Most influential descendants
- K202441: Eclipse II with Smart Noise Cancellation (2021), 1 descendant of its own
- K213307: Eclipse II with Smart Noise Cancellation (2022), 0 descendants of its own

## Indications for use
The software performs digital enhancement of a radiographic image generated by an x-ray device. The software can be used to process adult and pediatric x-ray images. This excludes mammography applications.

Source page: https://510kreport.com/device/K180809
Methodology: https://510kreport.com/methodology