UltraVision

GUDID B616UVXP0

General Purpose Diagnostic Medical Ultrasonic Imaging System

ULTRAVISION CORPORATION

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: B616UVXP0
• NIH Device Record Key: 8cdcfd99-c67b-43b0-8bb2-e559db387152
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraVision
• Version Model Number: XP
• Company DUNS: 080218827
• Company Name: ULTRAVISION CORPORATION
• 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: false
• 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

Customer Support Contacts

• Phone: 5616264055
• Email: info@ultravisionusa.com
• Phone: 5616264055
• Email: info@ultravisionusa.com
• Phone: 5616264055
• Email: info@ultravisionusa.com
• Phone: 5616264055
• Email: info@ultravisionusa.com
• Phone: 5616264055
• Email: info@ultravisionusa.com
• Phone: 5616264055
• Email: info@ultravisionusa.com
• Phone: 5616264055
• Email: info@ultravisionusa.com
• Phone: 5616264055
• Email: info@ultravisionusa.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B616UVXP0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150580

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, 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: 2020-11-30
• Device Publish Date: 2020-11-20

On-Brand Devices [UltraVision]

• B616UVXS0: General Purpose Diagnostic Medical Ultrasonic Imaging System
• B616UVXR0: General Purpose Diagnostic Medical Ultrasonic Imaging System
• B616UVXP0: General Purpose Diagnostic Medical Ultrasonic Imaging System
• B616UVXC0: General Purpose Diagnostic Ultrasonic Imaging System
• B616UVTKL1440: Linear Ultrasonic Transducer
• B616UVTKHL1840: Linear Ultrasonic Transducer
• B616UVTKCC520: Curved Ultrasonic Transducer