ExactVu High Resolution Micro-Ultrasound System EV-SYS-220

GUDID 00628055481010

The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System is comprised of transducers responsible for ultrasound signal generation and recording, a needle guide and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.

Exact Imaging Inc

General-purpose ultrasound imaging system

• Primary Device ID: 00628055481010
• NIH Device Record Key: dab3e88d-bcca-43bc-a1c3-0cdb983b24ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExactVu High Resolution Micro-Ultrasound System
• Version Model Number: 1.0
• Catalog Number: EV-SYS-220
• Company DUNS: 203044268
• Company Name: Exact Imaging 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628055481010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162972

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-08

On-Brand Devices [ExactVu High Resolution Micro-Ultrasound System]

• 00628055481027: The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical pro
• 00628055481010: The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical pro