Prismatik Dentalcraft, Inc 70-1047-COM0119 Inclusive

Cranial Navigation 4.1 is a software which enables navigated surgery when used with an Image Guided Surgery platform. It links patient anatomy (using reference arrays) and instruments in the real world or “patient space” to patient scan data or “image space”. This allows for the continuous localization of medical instruments and patient anatomy for medical interventions in cranial and craniofacial procedures.

For In Vitro Diagnostic UseSectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module.Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.

This database entry covers UDI for SW Versions 4.1 and higher: (01)04049471070026(10)411 -> Version 4.1.1; (01)04049471070026(10)420 -> Version 4.2; (01)04049471070026(10)421 -> Version 4.2.1; (01)04049471070026(10)423 -> Version 4.2.3; (01)04049471070026(10)424 -> Version 4.2.4, (01)04049471070026(10)425 -> Version 4.2.5, (01)04049471070026(10)426 -> Version 4.2.6

A mobile medical imaging software package that is used for the viewing, registration, fusion, and/or display for diagnosis of medical images. It can be used to review images, contours, DVH, and isodose curves from radiation treatment plans.