Velocity

GUDID 00854393006008

VARIAN MEDICAL SYSTEMS, INC.

Radiology DICOM image processing application software

• Primary Device ID: 00854393006008
• NIH Device Record Key: 1bdf0074-8327-48d8-8eae-7fd9f31795c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Velocity
• Version Model Number: 3.2
• 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	00854393006008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081076

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: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-20

On-Brand Devices [Velocity]

• 00854393006008: 3.2
• 00854393006039: 4.2