Velocity Medical Imaging Data Comparison Software

GUDID 00854393006022

VARIAN MEDICAL SYSTEMS, INC.

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• Primary Device ID: 00854393006022
• NIH Device Record Key: 9c7a9f81-b763-448d-a719-bb8200dad99b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Velocity Medical Imaging Data Comparison Software
• Version Model Number: 4.1
• Company DUNS: 059521914
• Company Name: VARIAN MEDICAL SYSTEMS, INC.
• 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	00854393006022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173636

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: 2
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-09-12

On-Brand Devices [Velocity Medical Imaging Data Comparison Software]

• 00854393006022: 4.1
• 00854393006015: 4.0