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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
Electrode junction box (256 channel)
NIHON KOHDEN CORPORATION
JE-120A-24
In Commercial Distribution
- 04931921108734 ()
JE-120A-24
- Electroencephalograph
Electrode junction box (192 channel)
NIHON KOHDEN CORPORATION
JE-120A-23
In Commercial Distribution
- 04931921108727 ()
JE-120A-23
- Electroencephalograph
Electrode junction box (128 channel)
NIHON KOHDEN CORPORATION
JE-120A-22
In Commercial Distribution
- 04931921108710 ()
JE-120A-22
- Electroencephalograph
Electrode junction box (64 channel)
NIHON KOHDEN CORPORATION
JE-120A
In Commercial Distribution
- 04931921108703 ()
JE-120A-21
- Electroencephalograph
EXTENDED LAN UNIT, JE-120A
NIHON KOHDEN CORPORATION
QI-124A
In Commercial Distribution
- 04931921108192 ()
QI-124A
- Electroencephalograph
BASE UNIT, JE-120A
NIHON KOHDEN CORPORATION
QI-123A
In Commercial Distribution
- 04931921108185 ()
QI-123A
- Electroencephalograph
No Description
Vysioneer Inc.
2.1.2
In Commercial Distribution
- 04719884900011 ()
- Radiology DICOM image processing application 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
Onduo App Android
VERILY LIFE SCIENCES LLC
SW0004
In Commercial Distribution
- 00860000249539 ()
- Self-care monitoring/reporting software
Onduo App iOS
VERILY LIFE SCIENCES LLC
SW0003
In Commercial Distribution
- 00860000249522 ()
- Self-care monitoring/reporting software
Onduo Care Team Console
VERILY LIFE SCIENCES LLC
SW0002
In Commercial Distribution
- 00860000249515 ()
- Self-care monitoring/reporting software
REMI Vigilenz AI for Event Detection
Epitel, Inc.
1.x.x
In Commercial Distribution
- 00860005388189 ()
20104
- Bioelectrical signal analysis software
FullFocus is a web-based software-only device for viewing and manipulating digital pathology images of glass slides obtained from the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS) on the monitor displays that are validated with verified test methods to meet required performance characteristics. FullFocus renders the uploaded slide images and is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis.
PAIGE.AI, INC.
2.X
In Commercial Distribution
- 00860007599101 ()
- Pathology information system
Automatic contouring for radiation treatment planning.
Quantitative Radiology Solutions LLC
QCCv1.0.0
Not in Commercial Distribution
- 00860006956004 ()
- Radiation therapy treatment planning workstation
No Description
Anumana, Inc.
v 2.3.0 (1010)
- Cardiopulmonary physiological parameter analysis software
The Low Ejection Fraction AI-ECG Algorithm interprets 12-lead ECG voltage times series data using an artificial intelligence-based algorithm. The device analyzes 10 seconds of a single 12-lead ECG acquisition, and within seconds provides a prediction of likelihood of LVEF (ejection fraction less than or equal to 40%) to third party software. The results are displayed by the thirdparty software on a device such as a smartphone, tablet, or PC. The Low Ejection Fraction AIECG Algorithm was trained to predict Low LVEF using positive and control cohorts, and the prediction of Low LVEF in patients is generated using defined conditions and covariates.
The Low Ejection Fraction AI-ECG Algorithm device is intended to address the unmet need for a point-of-care screen for LVEF less than or equal to 40% and is expected to be used by cardiologists, front-line clinicians at primary care, urgent care, and emergency care settings, where cardiac imaging may not be available or may be difficult or unreliable for clinicians to operate. Clinicians will use the Low Ejection Fraction AI-ECG Algorithm to aid in screening for LVEF less than or equal to 40% and making a decision for further cardiac evaluation.
Anumana, Inc.
v.2.2.0 (1010)
In Commercial Distribution
- 00860007426407 ()
- Cardiopulmonary physiological parameter analysis software
No Description
PathAI, Inc.
11124001
In Commercial Distribution
- 00860006696221 ()
- Histology/cytology/microbiology image-analysis interpretive software IVD
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