# K113725: Virtuost

- Pathway: 510(k) (Traditional)
- Applicant: O.N. Diagnostics
- Decided: Sep 13, 2012 after 269 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K890121 (1990). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983028: Fracture Risk Option for the QDR Bone Densitometer, Model#S QDR4500, QDR2000, QDR1500, QDR4000, QDR1000, QDR1000W, Hologic, Inc. (1998) Summary page 5.
- K894854: QCT Bone Mineral Density Analysis Software, Image Enhancements (1989) Summary page 5.
- K072664: GE Lunar Femur Strength Software, Ge Medical Systems Ultrasound and Primary Care Dia (2008) Summary page 5.
- K992246: QCT Bone Mineral Analysis Software, Image Analysis, Inc. (1999) Summary page 5.

## Most influential descendants
- K220402: VirtuOst (2023), 0 descendants of its own

## Indications for use
VirtuOst uses data from computed tomography scans to estimate bone mineral density, bone strength, and a load-to-strength ratio. This information can be used by a physician to assess fracture risk, identify ostebporosis, and monitor therapy. For pediatric patients, VirtuOst provides these estimates without any classifications and should be used only when the benefit of obtaining these estimates outweighs the risk of radiation.

Source page: https://510kreport.com/device/K113725
Methodology: https://510kreport.com/methodology