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510(k) Data Aggregation
K Number
K110971Device Name
TRACER IMPLANTATION KIT, INDEX IMPLANTATION KIT
Manufacturer
NAVOTEK MEDICAL LTD
Date Cleared
2012-01-10
(279 days)
Product Code
IYE, NEU
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
NAVOTEK MEDICAL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tracer Implantation Kit is indicated for use to radiographically and radioactively mark soft tissue for future therapeutic procedures.
The Tracer is indicated for permanent implantation in the prostate.
The Tracer is intended to be used in conjunction with the RealEye system as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator.
The IndeX Implantation Kit is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
The IndeX is intended to be used as a radiographic fiducial marker for visualization using x-ray, CT, or Cone Beam CT.
Device Description
The Tracer is a Platinum/Iridium radioactive soft tissue fiducial for implantation in the prostate, in or near the treatment target for radiotherapy treatments. The Tracer emits photons that enable its localization by the Navotek RealEye system that is designed to track localized gamma-emitting radioactive sources.
The implantation of the Tracer is performed using an Implantation Device, which is supplied with the Tracer pre-loaded within it. Therefore, the Tracer is supplied as a 'Tracer Implantation Kit' which includes the Tracer and the Implantation Device. The Tracer lmplantation Kit is provided in a single package, sterile (by gamma radiation) and ready for use. It is intended for single use only.
The IndeX is identical to the Tracer in all respects except that it is not radioactive. It is intended for use to radiographically mark soft tissue and to be visible in x-ray, CT, and Cone Beam CT images.
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K Number
K100625Device Name
REALEYE MODEL VCPS
Manufacturer
NAVOTEK MEDICAL LTD
Date Cleared
2011-01-21
(323 days)
Product Code
IYE
Regulation Number
892.5050Why did this record match?
Applicant Name (Manufacturer) :
NAVOTEK MEDICAL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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