# K223514: Spectral Bone Marrow

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Mar 9, 2023 after 107 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: 7 generations back to K013561 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121827: Gsi Viewer with Vue Option, GE Medical Systems SCS (2012) Summary page 4.

## Indications for use
Spectral Bone Marrow is an automated image processing software application, utilizing deep learning technology for bone segmentation, to facilitate optimized visualization of bone marrow in spectral body and extremity CT images. Spectral Bone Marrow’s output can be used during the review of traumatic and non-traumatic bone pathologies.

Source page: https://510kreport.com/device/K223514
Methodology: https://510kreport.com/methodology