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PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technologist / Operator in combination with Persyst EEG Review and Analysis Software on both adult and pediatric subjects at least 3 years of age for 3D visualization of the human brain function recorded with EEG and using a patient-specific MR image.
Clouds of Care
v2
- Bioelectrical signal analysis software
PreOp is intended for use by a trained/qualified EEG technologist or physician on both adult and pediatric subjects at least
3 years of age for the visualization of human brain function by fusing a variety of EEG information with rendered images
of an individualized head model and an individualized MRI image.
Clouds of Care
1.0.0
Not in Commercial Distribution
- 05430000733007 ()
- Bioelectrical signal analysis software
STarFix™ Designer DBS
FHC, INC.
C0265-01-00922
In Commercial Distribution
- 00873263009222 ()
C0265-01
- Stereotactic neuronavigation/planning system
STarFix™ Designer Laptop, 1x
FHC, INC.
C0267-00917
In Commercial Distribution
- 00873263009178 ()
C0267
- Stereotactic neuronavigation/planning system
No Description
Vysioneer Inc.
2.1.2
In Commercial Distribution
- 04719884900011 ()
- Radiology DICOM image processing application software
Contour+ (MVision AI Segmentation) provides a software interface to image analysis algorithms to be used in clinical workflows including, but not limited to, radiation therapy treatment planning workflows. The system includes processing tools for automatically contouring of imaging data of supported modalities CT and MRI using machine learning based algorithms. The produced segmentation templates for regions of interest are intended to be transferred to appropriate image visualization systems to be used as a template for a medical professional to visualize, modify and approve prior to further use in clinical workflows.
The system supports automatic contouring of pre-defined structures from common anatomical sites, i.e. Head and Neck, Brain, Breast, Lung and Abdomen, Male Pelvis, and Female Pelvis.
Contour+ (MVision AI Segmentation) is not intended to detect lesions or tumors. The device is not intended for use with real-time adaptive planning workflows.
Mvision AI Oy
1.2
In Commercial Distribution
- 06429830064206 ()
- Image segmentation application software
ASC Legacy™ 5.7mm-Compatible Titanium Blank
Preat Corporation
9008565
In Commercial Distribution
- 00842092183229 ()
9008565
- Dental implant suprastructure, permanent, preformed
ASC Legacy™ 4.5mm-Compatible Titanium Blank
Preat Corporation
9007565
In Commercial Distribution
- 00842092183212 ()
9007565
- Dental implant suprastructure, permanent, preformed
ASC Straumann® BLX-compatible WB Titanium Blank
Preat Corporation
9007265
In Commercial Distribution
- 00842092183205 ()
9007265
- Dental implant suprastructure, permanent, preformed
ASC Neodent® GM™ compatible Titanium Blank
Preat Corporation
9007165
In Commercial Distribution
- 00842092183199 ()
9007165
- Dental implant suprastructure, permanent, preformed