# K213307: Eclipse II with Smart Noise Cancellation

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Jan 14, 2022 after 102 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: 3 generations back to K060137 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202441: Eclipse II with Smart Noise Cancellation, Carestream Health, Inc. (2021) Summary page 4.

## 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/K213307
Methodology: https://510kreport.com/methodology