AccessGUDID - DEVICE: Velacur ONE (B995LI11000)

GUDID

Device Identifier (DI) Information

Brand Name: Velacur ONE
Version or Model: LI-1100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LI1100
Company Name: Sonic Incytes Medical Corp.

Primary DI Number: B995LI11000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203863610 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58710	Hepatic ultrasound elastography system	An assembly of mains electricity (AC-powered) devices, which may include rechargeable batteries, designed to measure liver stiffness/ultrasonic attenuation of tissues based on transient elastography for the evaluation/diagnosis of hepatic disease (e.g., liver fibrosis/steatosis); it may additionally be intended to measure spleen stiffness as an adjunct evaluation. It is typically used during diagnosis of chronic liver conditions such as viral hepatits, alcoholic hepatitis, and biliary disease, or for post-transplant evaluation. It consists of both a generator with dedicated software and a noninvasive applicator(s).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, Imaging, Pulsed Echo, Ultrasonic
ITX	Transducer, Ultrasonic, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K251728	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 400e1c77-bb04-41fc-9c08-a7fe98996014
Public Version Date: July 22, 2025
Public Version Number: 1
DI Record Publish Date: July 14, 2025