O N DIAGNOSTICS LLC

Address:1936 University Ave. Suite 280,Berkeley,CA,94704,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Densitometer, Bone (KGI) (1) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

Clear

VirtuOst - 00860000233101 Catalog Number :

Device Description : VirtuOst uses data from computed tomography scans to estimate bone mineral densi 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.

Device Class : 2

Duns Number: 145086513

Premarket Exempt : No

Product Code : KGI

Prescription Use : No

Device Count : 1

VirtuOst VFA - 00860000233118 Catalog Number :

Device Description : VirtuOst VFA uses sagittal sections from a spine-containing CT scan, with or wit 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.

Device Class : 2

Duns Number: 145086513

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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