No image
Margin Probe Console 2.0
The MARGINPROBE 2.0 System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins of the main ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer.
Details
Device typeIntraoperative tumour margin analyser: A mains electricity (AC-powered) unit designed for tissue surface analysis and characterization using radio-frequency (RF) spectroscopy, to identify cancerous tissue at the cut-lines (margins) during a lumpectomy procedure. It includes RF spectroscopy hardware, a monitor, and may include a suction pump to allow complete tissue contact; it is intended to be used with a dedicated probe (not included). Results are characterized (e.g., cancerous/non-cancerous) and displayed/labelled graphically (e.g., posterior, anterior, inferior, superior, medial, lateral), whereby surfaces identified as cancerous correspond to margins which may require further excision.
FDA categoryDiagnostic Low Electric Field
Device ID07290012534065
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information