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The PreOp Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study. The import process allows the user to select a DICOM CT scan series from any location that the user's computer sees as an available file source. 3D digital representations of various implant models are available in the planning software. Pre-Op Shoulder allows the user to digitally perform the surgical planning by showing a representation of the
patient's shoulder anatomy as a 3D model and allows the surgeon to place the implant in the patient's anatomy. The software allows the surgeon to generate a report, detailing the output of the planning activity. Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.
Instructions for use can be found at the following location: https://portal.si.genesisplanningsoftware.com/
Genesis Software Innovations LLC
2
In Commercial Distribution
- B973PREOPSHOULDER0 ()
- Image segmentation application software
The Preview Shoulder, a 3D total shoulder arthroplasty (TSA) surgical planning software, is a standalone software application which assists the surgeon in planning reverse and anatomic shoulder arthroplasty. Preview Shoulder includes 3D digital representations of implants for placement in images used for surgical planning. Preview Shoulder is a secure software application used by qualified or trained surgeons and is accessed by authorized users.
The primary function of Preview Shoulder is to receive and process DICOM CT image(s) of patients. Preview Shoulder can be used to place an implant in the original CT image and place an implant in the 3D model of reconstructed bone. The Preview Shoulder allow the user to perform surgical planning and generate an output surgical report. Preview Shoulder does not provide a diagnosis or surgical recommendation. The surgeon is responsible for selecting and placing the implant model for pre-surgical planning purposes.
Genesis Software Innovations LLC
1.29.1
In Commercial Distribution
- B973PREVIEWSHOULDER0 ()
PREVIEWSHOULDER
- Image segmentation application software
Orthodontic Software
PARK DENTAL RESEARCH CORP
O3D
In Commercial Distribution
- D769O3D0 ()
- CAD/CAM software
CEREC Ortho Software Version 2.0.0
SIRONA Dental Systems GmbH
6697986
In Commercial Distribution
- E27666979860 ()
- CAD/CAM software
CEREC Ortho Software Version 1.2.0
SIRONA Dental Systems GmbH
6611169
Not in Commercial Distribution
- E27666111690 ()
- CAD/CAM software
CEREC Ortho Software Version 2.1 Upgrade
SIRONA Dental Systems GmbH
6784495
In Commercial Distribution
- E27667844950 ()
- CAD/CAM software
CEREC Ortho Software Version 2.1
SIRONA Dental Systems GmbH
6748359
In Commercial Distribution
- E27667483590 ()
- CAD/CAM software
Imaging software
GENDEX CORP.
3
In Commercial Distribution
- EKAV101037680 ()
VIXWINPL
- Radiology information system application software
ATLASPLAN Software
INTEGRA LIFESCIENCES CORPORATION
ATLASSW
Not in Commercial Distribution
- M248ATLASSW1 ()
- 10381780252658 ()
- Neurological stereotactic surgery system
"ANS1 Software is inetended for use: ANS1 Software is an optional software accessory for use with the following models with datamanagement capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath
(Galvanic Skin response) and c) ES-BC (Body Composition Analyzer).When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS1software uploads the data of the devices, analyzes the data, and then displays the data in ac omputer for enhanced data management.
The ANS1 software is intended for use in clinical settings as an aid for health careprofessionals to review, analyze, and evaluate the historical tests results."
LD TECHNOLOGY, LLC
G001
In Commercial Distribution
- B322G0011 ()
- Manual-inflation electronic sphygmomanometer, non-portable
- Skin electrical conductance meter