# K171435: VirtuOst Vertebral Fracture Assessment

- Pathway: 510(k) (Traditional)
- Applicant: O.N. Diagnostics, LLC
- Decided: Aug 3, 2018 after 445 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: 3 generations back to K950611 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103475: Spineanalyer Model Sapoc, Optasia Medical (2011) Summary page 4.
- K023554: Dual-Energy Vertebral Assessment View Software, Ge Lunar Corp. (2002) Summary page 4.

## Indications for use
VirtuOst VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and measure vertebral deformities, classify the type and grade of any existing vertebral fracture, and from this identify patients at high risk of a future osteoporosis-related fracture. This information can be interpreted by a physician to diagnose existing vertebral fractures and to manage patients for osteoporosis.

Source page: https://510kreport.com/device/K171435
Methodology: https://510kreport.com/methodology