Dolphin/XF Robot Accessory

GUDID 07290016880229

The Dolphin/XF robot accessory, when used with the Dolphin system, is a device which assists the user in the acquisition of cerebral blood flow velocity

VIASONIX LTD

General-purpose ultrasound imaging system

• Primary Device ID: 07290016880229
• NIH Device Record Key: d9e0e5ac-7e52-4246-a2e6-ff04c2d57cab
• Commercial Distribution Discontinuation: 2021-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Dolphin/XF Robot Accessory
• Version Model Number: Dolphin/XF Robot Accessory
• 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	07290016880229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202742

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-08
• Device Publish Date: 2021-03-31

Devices Manufactured by VIASONIX LTD

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• 07290016880533 - Falcon/Xpress: 2025-01-06 The Falcon/Xpress is intended for use in the noninvasive evaluation of peripheral vascular pathology in patients.
• 07290016880489 - Pressure Cuff Size 12L: 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880496 - Pressure Cuff Size 2.5: 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880502 - Pressure Cuff Size 1.9: 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880519 - Pressure Cuff Size 1.6: 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880526 - Pressure Cuff Size 7: 2023-07-07 The intended use of the pressure cuffs is to measure non-invasively blood pressure
• 07290016880465 - Pressure Cuff Size 10: 2023-07-03 The intended use of the pressure cuffs is to measure non-invasively blood pressure