Falcon PVC0078

GUDID 07290016880014

intended for use in the noninvasive evaluation of peripheral vascular pathology in patients

VIASONIX LTD

General-purpose ultrasound imaging system

• Primary Device ID: 07290016880014
• NIH Device Record Key: f5ae45fe-14b9-44d8-a5cf-def69ba9b7fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Falcon
• Version Model Number: Quad
• Catalog Number: PVC0078
• Company DUNS: 533070236
• Company Name: VIASONIX LTD
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016880014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111416

FDA Product Code

• JOP: Transducer, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-21

On-Brand Devices [Falcon]

• 07290016880021: intended for use in the noninvasive evaluation of peripheral vascular pathology in patients
• 07290016880014: intended for use in the noninvasive evaluation of peripheral vascular pathology in patients
• 07290016880007: intended for use in the noninvasive evaluation of peripheral vascular pathology in patients