FAXITRON PATH USER MANUAL | HOLOGIC | REVISION 024
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This manual was created by Hologic
®
Inc. It is intended to guide the user on how to setup, install and use the Faxitron Path
hardware and the Vision Software System, both developed by Hologic
®
Inc..
Faxitron Path was previously known as PathVision
The user must first setup the hardware, then initiate the Vision Software. Please review the required setup procedures in Part 2
of this manual before continuing.
Indications for Use
The Faxitron Path is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens
from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy
procedure. Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the
time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.
Prescription use (Part 21 CFR 801 Subpart D)
Caution: Federal law restricts this device to sale by or on the order of a physician.
The system can operate as a standalone device. If connected to a network, it is critical that measures are implemented to
reduce the risk to patients by decreasing the likelihood that device functionality is intentionally or unintentionally compromised
by inadequate cybersecurity.
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