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510(k) Data Aggregation
K Number
K082354Device Name
STEREO NAVIGATOR ACCESSORY, STN-1000
Manufacturer
Date Cleared
2008-11-18
(95 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
NAVISCAN PET SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Stereo Navigator Accessory is an optional accessory to the PEM Flex® PET Scanner. It is intended for the localization of lesions in female breasts, as identified on a PET image. By using the Stereo Navigator, the physician is able to guide compatible interventional devices towards the PET abnormality as medically indicated. The Stereo Navigator also provides a means to confirm localization of the lesion in advance of the interventional procedure.
Device Description
The Stereo Navigator determines the three dimensional coordinates of a userdefined target for an imaged abnormality (e.g. lesion) displayed on the PEM Flex PET Scanner. Since PEM Flex tomographic images are displayed as a series of 2D planar slices, the user must define a target on two orthogonal images to define all three axis coordinates of the target location. These coordinates are processed into stereotactic information by the Stereo Navigator software which is used by the healthcare provider to position a stereotactic frame for guiding the trajectory of an interventional device and for determining the depth to which the interventional device should be inserted along the trajectory.
Additionally, the Stereo Navigator provides a means for the user to confirm that localization has been achieved during the interventional procedure and prior to sampling or marking. This is accomplished by placing an encapsulated positronemitting line source (radioactive line source) through the tissue access port (cannula) of the interventional device to the intended sampling or marking site, acquiring an image and comparing the location of the line source relative to the lesion (in at least two orthogonal image planes).
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