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SONIC INCYTES MEDICAL CORP

VELACUR · General Hospital

510(k): 1 Recall: 0 UDI: 2 MAUDE: 0 Class.: 66

510(k) Clearances (1)

Velacur One (LI-1100)

2025-06-26

Substantially Equivalent

UDI Registrations (2)

Velacur

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.

Velacur ONE

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 trai…

FDA Classification (66)

Digital Physical/Chemical Sterilization Process Sensor

General Hospital

Set, Blood Transfusion

General Hospital

Washer Of Body Waste Receptacles

General Hospital

Sterilizer, Dry Heat

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Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

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Infusion Safety Management Software

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Vascular Access Port Kit

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Tubing, Fluid Delivery

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Basin, Emesis

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Oral Administration Set

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Ear Irrigation Kit

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Nursing Pad, Cohesive Gel

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Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

General Hospital

Bottle, Collection, Vacuum

General Hospital

Thoracentesis Tray

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Delivery Room Apparel Kit

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Support, Scrotal, Therapeutic

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Whole Room Microbial Reduction Device

General Hospital

Detectors And Removers, Lice, (Including Combs)

General Hospital

Accessories To Examination Light

General Hospital

Stocking, Medical Support (For General Medical Purposes)

General Hospital

Blood Borne Pathogen Response Kit

General Hospital

Strip, Temperature, Forehead, Liquid Crystal

General Hospital

Pump, Infusion, Pca

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Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device

General Hospital

Stationary Infrared Thermometer

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Depressor, Tongue, Non-Surgical

General Hospital

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

General Hospital

Low Dead Space Needle, Single Lumen, Hypodermic

General Hospital

Warmer, Infant Radiant

General Hospital

Tubing, Noninvasive

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Administrations Sets With Neuraxial Connectors

General Hospital

Stapler, Surgical

General Hospital

Warmer, Thermal, Infusion Fluid

General Hospital

Rigid Sterilization Container With Software

General Hospital

Lubricant, Vaginal, Patient

General Hospital

Sterilizer, Steam

General Hospital

Mattress, Water, Temperature Regulated

General Hospital

Heparin Flush In 0.45% Sodium Chloride

General Hospital

Powder-Free Guayle Rubber Examination Glove

General Hospital

Thermometer Kit

General Hospital

Automated Endoscope Channel Cleaner

General Hospital

Cover, Mattress (Medical Purposes)

General Hospital

Fall Prevention Alarm/Sensor Attached Only

General Hospital

Rfid Chip For Dental Appliance

General Hospital

Bed, Manual

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Indicator, Biological, Liquid Chemical Sterilization Process

General Hospital

Mid-Stream Collection Kit

General Hospital

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

General Hospital

Central Venous Catheter Dressing Change Kit

General Hospital

Bottle, Hot/Cold Water

General Hospital

Chamber, Reverse Isolation, Patient Care

General Hospital

Peripheral Catheter Insertion Kit

General Hospital

Kit, Chemical Snake-Bite

General Hospital

Body Temperature Sensing Software

General Hospital

Image Processing Device For Estimation Of External Blood Loss

General Hospital

Lubricant, Patient

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Oral Lubricant

General Hospital

Implantable Radio Frequency Transponder System

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Water, Vascular Access Flush

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Buret Administration Intravenous Kit

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Allergen And Vaccine Delivery Needles

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Bed, Ac-Powered Adjustable Hospital

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Mattress And Bed Deck Cover (Medical Purposes)

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Unit, Neonatal Phototherapy

General Hospital

Infant Positioner, Rx, Use In Highly Monitored Setting

General Hospital