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Framewise Integrated Real-Time MRI Monitoring
Turing Medical Technologies Inc
v5
In Commercial Distribution
- 00860004785101 ()
- Length: 155 Millimeter
- Width: 65 Millimeter
- Height: 206 Millimeter
FIRMM®
- MRI system application software
The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature.
Sibel Health Inc.
810-00012
In Commercial Distribution
- 00860004541745 ()
- Wearable multiple vital physiological parameter monitor
SpineAR Surgical Navigation Advanced Platform (SNAP) Operating Room System
SURGICAL THEATER LLC
SpineAR
In Commercial Distribution
- 00860003884126 ()
- Surgical planning/navigation-enhancement system
SuRgical Planner (SRP) BrainStorm Desktop System
SURGICAL THEATER LLC
BrainStorm
In Commercial Distribution
- 00860003884119 ()
- Surgical simulation system
SyncAR Surgical Navigation Advanced Platform (SNAP) Operating Room System
SURGICAL THEATER LLC
SyncAR
In Commercial Distribution
- 00860003884102 ()
- Surgical planning/navigation-enhancement system
No Description
CAPTION HEALTH, INC.
Alastor
Not in Commercial Distribution
- 00860003586341 ()
- Ultrasound imaging system application software
The Caption Guidance software is intended to assist medical professionals in the acquisition of cardiac ultrasound images. Caption Guidance software is an accessory to compatible general purpose diagnostic ultrasound systems. Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2D-TTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5-Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).
CAPTION HEALTH, INC.
Apollo
Not in Commercial Distribution
- 00860003586334 ()
511-00021
- Ultrasound imaging system application software
Caption AI (Caption Guidance + Caption Interpretation) on portable handheld ultrasound.
The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5- Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).
The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation.
The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
CAPTION HEALTH, INC.
Adonis
511-00019
- Ultrasound imaging system application software
The Caption Guidance software is indicated for use in two-dimensional transthoracic echocardiography (2DTTE) for adult patients, specifically in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (AP4), Apical 5- Chamber (AP5), Apical 2-Chamber (AP2), Apical 3-Chamber (AP3), Subcostal 4-Chamber (SubC4), and Subcostal Inferior Vena Cava (SC-IVC).
The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM-compliant PACS system in order to provide automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation.
The Caption Interpretation Automated Ejection Fraction Software is indicated for use in adult patients.
CAPTION HEALTH, INC.
0.10, 0.11, 1.1, 1.2, 1.3, 1.4
Not in Commercial Distribution
- 00860003586303 ()
511-00003
- Ultrasound imaging system application software
Apollo arcc® is a Health Information System facilitating the combination of patient information received from another information system (HL7 interface) with clinical multimedia (images, video, audio and other formats) and clinical information in a highly organized and secure environment. Patient information may also be entered directly into arcc. The workflow is representative of standard clinical specialties including but not limited to pathology, gastroenterology, dermatology, surgery, etc. Digital media can be imported via TCP/IP or via digital capture through direct connection to a modality device (Ex. would be a microscope mounted camera).
APOLLO ENTERPRISE IMAGING CORP
01
In Commercial Distribution
- 00860002800301 ()
- Medical image management system
Koios Decision Support (DS) is a software application designed to assist trained interpreting physicians in analyzing breast and thyroid ultrasound images. The software device is a web application that is deployed to a Microsoft IIS web server and accessed by a user through a compatible client. Once logged in and granted access to the Koios DS application, the user examines selected breast or thyroid ultrasound DICOM images. The user selects Regions of Interest (ROIs) of orthogonal views of a breast lesion or thyroid nodule for processing by Koios DS. The ROI(s) are transmitted electronically to the Koios DS server for image processing and the results are returned to the user for review.
KOIOS MEDICAL, INC.
3.x
In Commercial Distribution
- 00860002545714 ()
- Ultrasound imaging system application software
The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques.
Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
KOIOS MEDICAL, INC.
2.x
In Commercial Distribution
- 00860002545707 ()
- Ultrasound imaging system application software
DOCS system is an audio/video integration system that is installed in health care facilities where video-assisted procedures are performed. The DOCS system is used by trained health care personnel to route video signals from medical equipment (i.e., endoscopic cameras, C-arms, ultrasound, PACS) to flat-panel monitors for display during procedures.
Cv Medical, LLC
DOCS
In Commercial Distribution
- 00860001554533 ()
- Medical image management system
The NuBOOM/DOCS system is an equipment management and audio/video integration system that is installed in health care facilities where video-assisted procedures are performed. The NuBOOM/DOCS system is used by trained health care personnel to route video signals from medical equipment (i.e., endoscopic cameras, C-arms, ultrasound, PACS) to flat-panel monitors for display during procedures.
The NuBOOM/DOCS system consists of two major components: an equipment management subsystem and a video integration subsystem.
The equipment management subsystem—called the NuBOOM—is a metal superstructure (cabinet) that is anchored to the facility floor. The cabinet provides an attachment point for booms, which support adjustable arms with flat-panel monitors, and shelves for storage of medical equipment. The booms and spring arms can be moved to allow the most ergonomic placement of the flat-panel monitors. The equipment management component of the NuBOOM/DOCS system provides health care staff with an adjustable system that can be configured to the needs of each procedure.
Cv Medical, LLC
U
In Commercial Distribution
- 00860001554526 ()
- Medical image management system
The NuCART® is a mobile display and image management platform intended to be used by health care providers
in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals
from source devices to monitors. It is tailored for use with a C-arm and Endo-Cam in MIS surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites.
Cv Medical, LLC
NuCART
In Commercial Distribution
- 00860001554519 ()
- Medical image management system
The NuVIEW® is a mobile visualization platform tailored for use with a C-arm and Patient Monitor in Minimally Invasive Surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites. Designed for mobility and simplicity it will compete with entry level mobile carts. The NuVIEW® product is comprised of Mechanical and Hardware design inputs.
Cv Medical, LLC
NuVIEW
In Commercial Distribution
- 00860001554502 ()
- Medical image management system
Magnetic Resonance Imaging System, Auxiliary Rack
Promaxo, Inc.
PR071-001-R
In Commercial Distribution
- 00860006901127 ()
PR071-001-R
- Full-body MRI system, permanent magnet
Magnetic Resonance Imaging System, Magnet Cart
Promaxo, Inc.
PR071-001-M
In Commercial Distribution
- 00860006901110 ()
PR071-001-M
- Full-body MRI system, permanent magnet
No Description
Analog Devices, Inc.
ADCP1100-WB-001
In Commercial Distribution
- 00860006382322 ()
- Wearable multiple vital physiological parameter monitoring system
No Description
Analog Devices, Inc.
ADI-CS-200-001
In Commercial Distribution
- 00860006382308 ()
- Wearable multiple vital physiological parameter monitoring system
No Description
Analog Devices, Inc.
ADCP1100-AT-001
In Commercial Distribution
- 00860006382346 ()
- Wearable multiple vital physiological parameter monitoring system
No Description
Analog Devices, Inc.
ADCP-1100-BS-001
In Commercial Distribution
- 00860006382339 ()
- Wearable multiple vital physiological parameter monitoring system
No Description
Analog Devices, Inc.
ADCP1100-PL-001
In Commercial Distribution
- 00860006382315 ()
- Wearable multiple vital physiological parameter monitoring system
Localization and characterization of thyroid ultrasound images.
SEE-MODE TECHNOLOGIES PTE. LTD.
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
In Commercial Distribution
- 00860006305727 ()
- Ultrasound imaging system application software
Analysis and reporting of vascular ultrasound images
SEE-MODE TECHNOLOGIES PTE. LTD.
AVA (Augmented Vascular Analysis)
In Commercial Distribution
- 00860006305703 ()
- Ultrasound imaging system application software
MediScout® is an augmented reality accessory to clinical ultrasound (US) systems, with the ability to holographically display the US image for the user as well as provide procedural annotation and a teleprodecural function for remote practitioner collaboration.
Mediview Xr, Inc.
MS-100-1001
In Commercial Distribution
- 00860006066307 ()
- Ultrasound imaging system application software
No Description
CORTECHS LABS INC
NQ BT
In Commercial Distribution
- 00860000004824 ()
- MRI system application software
Vital Signs ViewStation
Philips Medical Systems Hsg
Vital Signs ViewStation
Not in Commercial Distribution
- 00884838009578 ()
863067
- Centralized patient monitor
No Description
Philips Medizin Systeme Böblingen GmbH
865040
Not in Commercial Distribution
- 00884838000278 ()
865040
- Multiple vital physiological parameter monitoring system, clinical
No Description
Philips Medizin Systeme Böblingen GmbH
865039
Not in Commercial Distribution
- 00884838000261 ()
865039
- Multiple vital physiological parameter monitoring system, clinical
IntelliVue MP5 Configured Patient Monitor with 8.4" TFT SVGA display. Primary input device is Touch.
Philips Medizin Systeme Böblingen GmbH
IntelliVue MP5
In Commercial Distribution
- 00884838000230 ()
865024
- Multiple vital physiological parameter monitoring system, clinical
The IntelliVue MX850 Patient Monitor has an optically-bonded 22 inch (547 mm) LCD (TFT) widescreen display with projected capacitive touch technology. It is compatible with various measurement modules and measurement servers. The monitor provides as standard a 100BaseT LAN port, an RS232 port, four USB ports, a basic nurse call relay, and an analog ECG sync output. MX850 also provides two MSL connectors for connecting up to two FMX-4 module racks (either in parallel or serial). Built-in to the front of the display is a Contactless ID and Communication module using RFID technology. Please refer to technical data sheet for more information.
Philips Medizin Systeme Böblingen GmbH
IntelliVue Patient Monitor MX850
In Commercial Distribution
- 00884838070790 ()
866470
- Multiple vital physiological parameter monitoring system, clinical
No Description
Philips Medizin Systeme Böblingen GmbH
867059
Not in Commercial Distribution
- 00884838064904 ()
867059
- Multiple vital physiological parameter monitoring system, clinical
Software medical device, used with a Philips Interventional X-Ray System. Creates a CT based 3D model of the coronary vessel tree. Provides a composite image of 2D X-ray exposure image and 3D model.
Philips Medical Systems Nederland B.V.
CT Trueview - 2
In Commercial Distribution
- 00884838064782 ()
001010
- Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Intended to assist in the treatment of endovascular diseases during an endovascular intervention procedure.
Philips Medical Systems Nederland B.V.
VesselNavigator - 1
In Commercial Distribution
- 00884838064775 ()
001013
- Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Intended to assist with saccular cerebral aneurysm embolization, by visualizing and quantifying blood flow changes.
Philips Medical Systems Nederland B.V.
AneurysmFlow - 1
In Commercial Distribution
- 00884838064768 ()
001015
- Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Reconstructs 3D volumes from rotational fluoroscopic acquisitions and provides CT-like images to assist the physician.
Philips Medical Systems Nederland B.V.
XperCT Dual - 3
In Commercial Distribution
- 00884838059306 ()
001105
- Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Extension of XperCT. Assists physicians with embolization of hypervascular tumors in the liver using interventional X-ray.
Philips Medical Systems Nederland B.V.
EmboGuide - 1
In Commercial Distribution
- 00884838059290 ()
001012
- Angiographic x-ray system application software
Software medical device. Assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo guidance.
Philips Medical Systems Nederland B.V.
EchoNavigator - 2
Not in Commercial Distribution
- 00884838059283 ()
001011
- Angiographic x-ray system application software
Software medical device, used with a Philips Interventional X-Ray System. Provides a color coded representation of a digital subtraction angiography (DSA).
Philips Medical Systems Nederland B.V.
2D Perfusion - 1
In Commercial Distribution
- 00884838059276 ()
001008
- Angiographic x-ray system application software