Velacur

GUDID B995LI10050

Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised of a control unit, activation unit, and ultrasound probe. A carrying case is also provided.

Sonic Incytes Medical Corp.

Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system Hepatic ultrasound elastography system

• Primary Device ID: B995LI10050
• NIH Device Record Key: b527a4d0-1b2b-4223-a000-81e7a27a1fda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Velacur
• Version Model Number: LI-1005
• Company DUNS: 203863610
• Company Name: Sonic Incytes Medical Corp.
• 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: 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
HIBCC	B995LI10050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201597

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: 2
• Public Version Date: 2020-11-30
• Device Publish Date: 2020-11-13