FDA.reportPublic FDA data

Velacur ONE

Primary DI
B995LI11000
Brand
Velacur ONE
Company
Sonic Incytes Medical Corp.
Model
LI-1100
Catalog number
LI1100
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.
Published
2025-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251728000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251728000Velacur One (LI-1100)Sonic Incytes Medical Corp2025-06-26IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B995LI11000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hepatic ultrasound elastography systemAn 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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203863610
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B995LI10050VelacurLI-10052020-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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