VirtuOst
O.N. Diagnostics
O.N. DIAGNOSTICS, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010687441 | 3010687441 | O.N. DIAGNOSTICS, LLC | 1 | N | 2026-01-01 | 1936 University Ave. Suite 280 Berkeley CA US 94704 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 166853 | 1542849504 | K171435 | VirtuOst Vertebral Fracture Assessment | LLZ | 2018-08-03 |
| 166853 | 1581011418 | K113725 | VIRTUOST | KGI | 2012-09-13 |
Product Codes Associated With Registrations#
PMN#
GUDID#
VirtuOst VFA - 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.
2018-08-15
VirtuOst - 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 osteoporosis, 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.
2018-08-15