# K083691: Bonevue

- Pathway: 510(k) (Traditional)
- Applicant: Micromri, Inc.
- Decided: Feb 25, 2009 after 75 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K913770 (1991). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070831: Voxar 3D Enterprise with Colonmetrix and Pet/CT Perfusion, Barcoview Mis Edinburgh (2007) Summary page 1.
- K011142: Aquarius Workstation, Terarecon,Inc. (2001) Summary page 1.
- K071331: Vitrea Version 4.0, Vital Images, Inc. (2007) Summary page 1.
- (no number) Visual Medical System: named in the summary without a submission number

## Indications for use
BoneVue is a software tool for 3D visualization of bone micro-architecture using MRI datasets with the possibility of manual or automated measurements of descriptive parameters regarding cortical and trabecular morphology. BoneVue is a workflow tool intended to assist a trained physician in the assessment of high-resolution MRI datasets of bone.

Source page: https://510kreport.com/device/K083691
Methodology: https://510kreport.com/methodology