Velacur ONE LI1100

GUDID B995LI11000

Velacur ONE is an ultrasound medical device used to provide estimates of tissue stiffness, ultrasound attenuation and Velacur Determined Fat Fraction (VDFF). These are meant to be used in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases, including hepatic steatosis. The device is intended to be used in a clinical setting and by trained medical professionals.

Sonic Incytes Medical Corp.

Hepatic ultrasound elastography system

• Primary Device ID: B995LI11000
• NIH Device Record Key: 400e1c77-bb04-41fc-9c08-a7fe98996014
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Velacur ONE
• Version Model Number: LI-1100
• Catalog Number: LI1100
• Company DUNS: 203863610
• Company Name: Sonic Incytes Medical Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B995LI11000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251728

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: 2025-07-22
• Device Publish Date: 2025-07-14

Devices Manufactured by Sonic Incytes Medical Corp.

• B995LI11000 - Velacur ONE: 2025-07-22Velacur ONE is an ultrasound medical device used to provide estimates of tissue stiffness, ultrasound attenuation and Velacur Determined Fat Fraction (VDFF). These are meant to be used in conjunction with other clinical indicators in order to aid in clinical management of patients with liver diseases, including hepatic steatosis. The device is intended to be used in a clinical setting and by trained medical professionals.
• 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: 2020-11-30 Velacur is a portable ultrasonic elastography machine used to assess and monitor chronic liver diseases. The device is comprised