# K223424: Spine Auto Views

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Jul 13, 2023 after 241 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: 11 generations back to K954678 (1996). 88 ancestors in all.
No later device cites it as a predicate yet.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183204: Bone VCAR (BVCAR), GE Medical Systems SCS (2019) Summary page 5.

## Indications for use
Spine Auto Views is a non-invasive image analysis software package which may be used in conjunction with CT images to aid in the automatic generation of anatomically focused multi-planar reformats and automatically export results to pre-determined DICOM destinations. Spine Auto Views assists clinicians by providing anatomically focused reformats of the spine, with the ability to apply anatomical labels of the vertebral bodies and intervertebral disc spaces. Spine Auto Views may be used for multiple care areas and is not specific to any disease state. It can be utilized for the review of various types of exams including trauma, oncology, and routine body.

Source page: https://510kreport.com/device/K223424
Methodology: https://510kreport.com/methodology