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510(k) Data Aggregation
K Number
K081042Device Name
MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES
Manufacturer
Date Cleared
2008-09-03
(145 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
BSD MEDICAL SYSTEMS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures.
The MTX-100 microwave applicators, which are inserted using the provided OTN catheters, may be used in open surgical as well as percutaneous ablation procedures. Optional temperature sensors may be used to monitor tissue temperatures.
Device Description
The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers microwave energy for coagulation (ablation) of soft tissue. The delivery of microwave energy is controlled by time and power parameters set by the operator. The system consists of a mobile generator, generator cart, microwave applicators, Over-The-Needle (OTN) catheters for applicator can minorwing and optional temperature sensors and temperature sensor positioning tubes. The mobile generator is comprised of a computer, microwave generator, theoring the based temperature monitoring system, and thermal calibration well. The operator interface is via a touchscreen monitor.
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