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510(k) Data Aggregation
K Number
K232957Device Name
Sterile and Non-Sterile Ultrasound Gels
Manufacturer
Jianerkang Medical Co., Ltd
Date Cleared
2023-12-15
(85 days)
Product Code
MUI
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
Jianerkang Medical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile and Non-Sterile Ultrasound Gels is intended to be used on external, intact skin as a coupling contact medium for ultrasonic procedures. The sterile Ultrasound Gel is also used for intra operative, biopsy applications. The Ultrasound Gel can be used during the procedures that involved adults and pediatrics in professional healthcare facility by qualified and trained healthcare professional.
Device Description
The proposed device, Sterile and Non-Sterile Ultrasound Gels, are non- irritating, nonsensitizing acoustic couplants intended for use as a scanning gel in medical diagnostic ultrasound procedures. The gel is an accessory used to couple sound waves between the patient and the medical imaging electronic transducers during diagnostic ultrasound procedures. Ultrasound gel is a type of conductive medium that enables a tight bond between the skin and the probe or transducer, allowing the waves to transmit directly to the tissues beneath and to the parts that need to be imaged. As such, the gel is formulated to improve the acoustic transmission of sound waves to create the ultrasound image.
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