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510(k) Data Aggregation
K Number
K151070Device Name
Sonishield 100 Antimicrobial Ultrasound Gel
Manufacturer
Quotient Medical
Date Cleared
2016-01-13
(267 days)
Product Code
MUI
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
Quotient Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sonishield™ 100 Antimicrobial Ultrasound Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external and therapeutic ultrasound imaging procedures. It is placed on the patient's skin prior to initiating an ultrasound examination. It is indicated for prescription use only.
Device Description
Sonishield™ 100 Antimicrobial Ultrasound Gel consists of deionized water, hydroxyethylcellulose, propanediol and benzalkonium chloride. It is a type of conductive medium (i.e.) scanning gel used in ultrasound therapeutic and diagnostic imaging techniques. A scanning gel acts as a couplant that provides an acoustic pathway between the transducer and the skin. In addition, the gel eliminates air (a disruptive influence) from the interface and adapts the contours of the probe to the skin.
The major characteristics of Sonishield™ 100 Antimicrobial Ultrasound Gel include:
- Hypoallergenic, non-irritating
- Water soluble, non-staining and easily cleanable
- . Does not contain oil or fatty matter
- Free from formaldehyde and salt ●
- No toxic effects
- Produced as a completely harmless material
- Has no odor
- Vacuum treated production
- Does not damage the probe
- Does not contain air bubbles
- pH level ranges from 4.5 to 6.5 at 25°C ●
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