VirtuOst

GUDID 00860000233101

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.

O N DIAGNOSTICS LLC

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• Primary Device ID: 00860000233101
• NIH Device Record Key: 0f7b9f50-6668-404a-a17f-85c5b0b3bfb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VirtuOst
• Version Model Number: A
• Company DUNS: 145086513
• Company Name: O N DIAGNOSTICS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000233101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113725

FDA Product Code

• KGI: Densitometer, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-07
• Device Publish Date: 2018-08-15

Devices Manufactured by O N DIAGNOSTICS LLC

• 00860000233101 - VirtuOst: 2019-10-07VirtuOst 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.
• 00860000233101 - VirtuOst: 2019-10-07 VirtuOst uses data from computed tomography scans to estimate bone mineral density, bone strength, and a load-to-strength ratio.
• 00860000233118 - VirtuOst VFA: 2019-10-07 VirtuOst VFA uses sagittal sections from a spine-containing CT scan, with or without contrast enhancement, to visualize and meas