# K133442: Bone Suppression Software

- Pathway: 510(k) (Traditional)
- Applicant: Carestream Health, Inc.
- Decided: Mar 11, 2014 after 119 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: 6 generations back to K862120 (1986). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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 1.
- K092363: Softview, Model 2.01, Riverain Medical Group (2010) Summary page 1.

## Indications for use
The software's intended use is to assist diagnosis of chest pathology by minimizing anatomical distractions such as the ribs and clavicle in chest x-ray images.

Source page: https://510kreport.com/device/K133442
Methodology: https://510kreport.com/methodology