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510(k) Data Aggregation
K Number
K053463Device Name
AIM ACCURACY IN MARKING SYSTEM
Manufacturer
Date Cleared
2006-03-07
(84 days)
Product Code
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
GEORGENE AUSTRIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Accuracy In Marking® is a marking device used in conjunction with a transducer during vascular mapping. The device allows the user to mark a vascular area immediately when it is identified during mapping process. The guide path underneath the transducer allows the user to identify the target vessel prior to marking. The product is supplied non-sterile and is intended for single use only.
Device Description
The marking device is enables the sonographer to mark the "targeted" vessel during vascular mapping. The shadow guide is an adhesive "film" adhered directly underneath the footing of the transducer used as guide on identifying the vessel. The marking device and the "shadow guide" are attached to a transducer using a non-latex adhesive. The device shall be sold non-sterile for single use only. This device is compatible with FDA approved linear and curved linear ultrasonic transducers in the frequency of 4MHz to 12MHz.
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