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LOCalizer, Breast Biopsy System
MANUFACTURER : HOLOGIC

Device for the detection of non-palpable lesions of the breast using an RFIDtag radio frequency identification tag, suitable for detection by mammography, ultrasound or MRI examination.

DETAILED DESCRIPTION
TECHNICAL SPECIFICATIONS
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The LOCalizer system marks the lesion with a miniature radiofrequency. The tag is designed to be implanted into the breast at any time prior to the day of surgery. No surgical wires may result in less stress for the patient and no more localization scheduling conflicts. The handheld Reader displays the distance to the Tag in millimeters and the Tag’s ID number on a bright screen, making it easy to read during the procedure. The LOCalizer system can read the tag from at least up to 60mm distance. The Surgical Probe is a pencilsized, single-use sterile probe that will guide the surgeon towards the Tag during the operation. The 8mm diameter of the probe allows for smaller incisions. The LOCalizer system was designed to report distance to the Tag without any lag or delay.

Handheld Reader Details:
Dimensions:

  • Width = 73.7 mm (2.9 inches)
  • Length = 165 mm (6.5 inches)
  • Thickness = 22.9 mm (0.9 inches)
  • Weight = 206 g

Loop Probe Specifications:
Dimensions:

  • inner diameter = 12mm
  • outer diameter = 39mm
  • Max Reading Depth: 6cm

Average Positional Accuracy: ± 1mm

Surgical Probe:

Dimensions: 175mm long, 8mm diameter

Max Reading Depth: 3cm

Tag Applicator: Applicator consists of a plastic molded handle and a beveled 12 GA introducer needle with locking plunger. Dimensions: Needles are provided in approximately 5, 7, or 10cm lengths and include 1cm depth reference marks.
Dimensions: 10.6mm long, 2mm diameter