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Abbott RealTime HCV Genotype II m2000 System Combined Application CD-ROM, Version 1.0
ABBOTT MOLECULAR INC.
08L21-01
In Commercial Distribution
- 00884999034266 ()
08L21-01
- Laboratory instrument/analyser application software IVD
LENS CONNECTED TOWER APPLICATION
Smith & Nephew, Inc.
72205347
In Commercial Distribution
- 00885556778777 ()
72205347
- Operating room audiovisual data/device management system application software
Venue Sprint R6 MD
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R6
In Commercial Distribution
- 00198953001387 ()
- Ultrasound imaging system application software
Caption AI on Vscan
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
AI
In Commercial Distribution
- 00198953030233 ()
- Ultrasound imaging system application software
No Description
MCKESSON TECHNOLOGIES INC.
15.2
In Commercial Distribution
- 80010939010014 ()
- Anaesthesia information system application software
InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest.
Infervision Medical Technology Co., Ltd
5.0.2.5
In Commercial Distribution
- 00850003095042 ()
- X-ray image interpretive software
- Diagnostic x-ray digital imaging system workstation
Computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during review of CT examinations of the chest.
Infervision US Inc
2.1.2.1
In Commercial Distribution
- 00850003095004 ()
- X-ray image interpretive software
- Diagnostic x-ray digital imaging system workstation
A standalone HeRO monitor for two infants
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution
- 00865536000234 ()
- Neonatal/paediatric heart rate monitoring application software
- Neonatal/paediatric heart rate monitoring hardware
A HeRO System for the private room
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution
- 00865536000227 ()
- Neonatal/paediatric heart rate monitoring application software
- Neonatal/paediatric heart rate monitoring hardware
No Description
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution
- 00865536000210 ()
- Neonatal/paediatric heart rate monitoring application software
- Neonatal/paediatric heart rate monitoring hardware
Server based HeRO System
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution
- 00865536000203 ()
- Neonatal/paediatric heart rate monitoring hardware
- Neonatal/paediatric heart rate monitoring application software
No Description
CLEAR GUIDE MEDICAL, INC.
CGSCENERGY
In Commercial Distribution
- B201CGSCENERGY1 ()
- B201CGSCENERGY0 ()
- Ultrasound imaging system application software
- Stereotactic system application software
72TB server for use with the Genius™ Digital Diagnostics System for short term digital storage.
Hologic, Inc.
INFORMATION MANAGEMENT SYSTEM, LARGE
In Commercial Distribution
- 15420045513976 ()
ASY-14451
- Microscope slide digital imaging scanner IVD
- Laboratory instrument/analyser application software IVD
32TB server for use with the Genius™ Digital Diagnostics System for short term digital storage.
Hologic, Inc.
INFORMATION MANAGEMENT SYSTEM, BASE
In Commercial Distribution
- 15420045513921 ()
ASY-14305
- Laboratory instrument/analyser application software IVD
- Microscope slide digital imaging scanner IVD
Norav 1200 Series PC-ECG Software Kit with the following Option(s):
- Upgrade from SOFT-NH300-1 to SOFT-NH301-4,Kit
The Kit includes:
Software Protection Key - "HASP-Key"
Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH300 DL-Rv to 301
In Commercial Distribution
- 07290110252694 ()
HASP-SW-KNH300-1-UP-1
- Electrocardiographic long-term ambulatory recording analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s):
- I2 = Resting-ECG Measurement and Advanced Interpretation
The Kit includes:
Software Protection Key - "HASP-Key"
Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW I2
In Commercial Distribution
- 07290110252632 ()
HASP-SW-K-I2-01
- Patient-administration information system application software
- Cardiopulmonary stress exercise monitoring system computer
- Cardiovascular risk evaluation interpretive software
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.
Eko Devices, Inc.
v7.x
In Commercial Distribution
- 00850010298146 ()
ELEFT
- Cardiopulmonary physiological parameter analysis software
No Description
Magstim, Inc.
6150036
In Commercial Distribution
- 00850033571028 ()
- Electroencephalograph
No Description
Sugarmate, LLC
1008182
In Commercial Distribution
- 00850018992626 ()
- Self-care monitoring/reporting software
No Description
Sugarmate, LLC
1008181
In Commercial Distribution
- 00850018992619 ()
- Self-care monitoring/reporting software
No Description
Sugarmate, LLC
1008180
In Commercial Distribution
- 00850018992602 ()
- Self-care monitoring/reporting software
No Description
Sugarmate, LLC
1007228
In Commercial Distribution
- 00850018992435 ()
- Self-care monitoring/reporting software
No Description
Bigfoot Biomedical, Inc.
SW-300983
In Commercial Distribution
- 00850003506517 ()
SW-300983
- Self-care monitoring/reporting software
Mobile application used by patients for disease management
Takeda Pharmaceuticals U.S.A., Inc.
V2
In Commercial Distribution
- 00850025688826 ()
- Home pharmaceutical management support software
Web application used by Healthcare Professionals to generate dose calculations
Takeda Pharmaceuticals U.S.A., Inc.
V3
In Commercial Distribution
- 00850025688819 ()
- Home pharmaceutical management support 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
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
Automatic contouring for radiation treatment planning.
Quantitative Radiology Solutions LLC
QCCv1.0.0
Not in Commercial Distribution
- 00860006956004 ()
- Radiation therapy treatment planning workstation
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
No Description
Anumana, Inc.
v 2.3.0 (1010)
- Cardiopulmonary physiological parameter analysis software
No Description
PathAI, Inc.
11124001
In Commercial Distribution
- 00860006696221 ()
- Histology/cytology/microbiology image-analysis interpretive software IVD
REMI Vigilenz AI for Event Detection
Epitel, Inc.
1.x.x
In Commercial Distribution
- 00860005388189 ()
20104
- Bioelectrical signal analysis software
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
The Stratus EEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well video synchronized to the EEG. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal.
The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Kvikna Medical ehf.
Acquisition
- Bioelectrical signal analysis software
The Lifelines iEEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Acquisition systems consist of the Lifelines iEEG software, an EEG amplifier and an off the shelf computer, along with various additional options such as video cameras (1 or 2), a photic stimulator and a bag or a cart for the system.
Kvikna Medical ehf.
Acquisition
Not in Commercial Distribution
- 05694110063090 ()
- Electroencephalographic monitoring system
- Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW2050
Not in Commercial Distribution
- 05694110063083 ()
- Electroencephalograph
- Electroencephalographic monitoring system
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1050
Not in Commercial Distribution
- 05694110063076 ()
- Electroencephalographic monitoring system
- Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1040
Not in Commercial Distribution
- 05694110063045 ()
- Electroencephalographic monitoring system
- Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1030
Not in Commercial Distribution
- 05694110063038 ()
- Electroencephalographic monitoring system
- Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1010
Not in Commercial Distribution
- 05694110063021 ()
- Electroencephalographic monitoring system
- Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1022
Not in Commercial Distribution
- 05694110063014 ()
- Electroencephalographic monitoring system
- Electroencephalograph
The Lifelines iEEG medical device is intended for acquisition and review of EEG and other physiological data as well as digital video synchronized to the EEG. It offers industry standard features such as re-montaging and band pass filtering. Furthermore it offers spectral analysis in the form of trend analysis and user selected sections of EEG.
Kvikna Medical ehf.
KHW1020
Not in Commercial Distribution
- 05694110063007 ()
- Electroencephalograph
- Electroencephalographic monitoring system
Persyst ESI powered by Epilog provides Electrical Source Imaging as a service to a clinical user. The clinical user does not interact directly with the device. In the Persyst ESI powered by Epilog service, the device is used by Epilog operators to generate a report.
Persyst ESI powered by Epilog 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
v2
- Bioelectrical signal analysis software