VirtuOst VFA

GUDID 00860000233118

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.

O N DIAGNOSTICS LLC

Radiology DICOM image processing application software

• Primary Device ID: 00860000233118
• NIH Device Record Key: 18dcfe5c-7313-45f8-b9d8-067733726ee4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VirtuOst VFA
• 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	00860000233118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171435

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2019-10-07 VirtuOst uses data from computed tomography scans to estimate bone mineral density, bone strength, and a load-to-strength ratio.
• 00860000233118 - VirtuOst VFA: 2019-10-07VirtuOst 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.
• 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