# K223261: Open Rib

- Pathway: 510(k) (Traditional)
- Applicant: Canon Medical Informatics, Inc.
- Decided: Jul 13, 2023 after 262 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K954678 (1996). 87 ancestors in all.
No later device cites it as a predicate yet.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123584: Syngo, CT Bone Reading, Siemens Medical Solutions USA, Inc. (2013) Summary page 4.

## Indications for use
Open Rib is image analysis software for chest CT images. Open Rib offers a visualization of the unfolded rib cage that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventional multiplanar reformat views. Open Rib offers geometric and HU measurement tools.

Source page: https://510kreport.com/device/K223261
Methodology: https://510kreport.com/methodology