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510(k) Data Aggregation
K Number
K113680Device Name
SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT
Manufacturer
SOMA ACCESS SYSTEMS LLC
Date Cleared
2011-12-29
(14 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
SOMA ACCESS SYSTEMS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
Device Description
The Soma Access Systems ExactTrack™ I Procedure Kit consists of five disposable, sterile components: (1) needle/hub/magnet and needle protective sheath assembly, (2) cable sleeve, (3) elastic bands, (4) top shield assembly, and (5) bottom shield assembly. The needle/hub/magnet assembly consists of the needle, hub, magnet, and needle protective sheath. The needle is 18 gauge stainless steel and accepts a standard guidewire; the hub is an industry standard configuration modified to retain the magnet which is detected by OEM equipment electromagnetic sensors; the needle sheath protects the needle/hub/magnet during packaging and transportation. The cable sleeve is attached at one end to the assembled top and bottom shield by an elastic band and extends over the ultrasound transducer cable to prevent the transducer cable from coming in direct contact with the sterile field. The top and bottom shields' configuration has been designed to snap together while fitting tightly over OEM transducers. The top and bottom shields utilize a needle guide and needle lock during ultrasound procedures.
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