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

• 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

Devices Manufactured by Sonic Incytes Medical Corp.

• B995LI11000 - Velacur ONE: 2025-07-22 Velacur ONE is an ultrasound medical device used to provide estimates of tissue stiffness, ultrasound attenuation and Velacur De
• B995LI10050 - Velacur: 2020-11-30Velacur 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.
• B995LI10050 - Velacur: 2020-11-30 Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised