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510(k) Data Aggregation
K Number
K143396Device Name
omni TRAX Active Patient Tracker
Manufacturer
CIVCO Medical Instruments Co Inc dba CIVCO Medical Solutions
Date Cleared
2015-01-23
(58 days)
Product Code
IYO, LNH
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
CIVCO Medical Instruments Co Inc dba CIVCO Medical Solutions
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended to provide physicians with a tool for electromagnetic (EM) tracking of instruments with respect to pre-acquired or real-time data. The device is intended for use in Magnetic Resonance Imaging (MRI) and ultrasound (US) environments.
Device Description
The proposed device contains multiple fluid-filled cavities that serve as registration points (markers) in MR. Adhesive tape on the bottom of the proposed device is used to secure the device to the patient. Skin marking areas allow for repositioning in both MR and ultrasound environments. The device also provides a connection point for an electromagnetic sensor accessory. The proposed device is provided non-sterile, is intended for single patient use, and is manufactured of non-magnetic materials. The proposed device enables automatic or manual image fusion of real-time ultrasound to previously acquired MR data sets. The proposed device may also be used to aid in image fusion of real-time ultrasound to previously acquired ultrasound data sets.
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