# K183204: Bone VCAR (BVCAR)

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Apr 8, 2019 after 140 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.
1 later device descends from it; 1 cites it directly.
0 of 89 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 5.

## Most influential descendants
- K223424: Spine Auto Views (2023), 0 descendants of its own

## Indications for use
Bone VCAR is a post processing application for use in the analysis of CT images. The software is intended to support clinicians in the review of images that include the spine by providing tools to label the spine and optimize the display of anatomy within the CT image. Bone VCAR is designed to support the clinician in visualization of the spine, by providing initial identification of vertebrae to assist in report dictation. The software also assists the user by providing optimized display settings for easier identification of anatomy to facilitate fast image review and reporting of findings. Bone VCAR may be used for multiple care areas and is not specific to any disease state. It can be utilized during the review of various types of exams including trauma, oncology, and routine body.

Source page: https://510kreport.com/device/K183204
Methodology: https://510kreport.com/methodology