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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
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
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
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
Vitazi Telehealth Portal is web-facing software used to screen patients for diabetic retinopathy (DR). The Vitazi Telehealth Portal is a software medical device. The
purpose of the Vitazi Telehealth Portal is to allow licensed medical providers to review and interpret medical images.
Vitazi.Ai, Inc.
0.0.8
In Commercial Distribution
- 00860012221608 ()
- Medical image management system
GutTracker measures GI motility of the stomach, small intestine and colon non-invasively over multiple days as patients go about their normal daily lives.The intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.
G-TECH MEDICAL, INC.
Gen 2
In Commercial Distribution
- 00860011391500 ()
- 00860011391517 ()
- Length: 3.3 Inch
1001
- Wearable multiple vital physiological parameter monitoring system
No Description
Sirona Medical, Inc.
Model1
In Commercial Distribution
- 00860011175803 ()
- Radiology information 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
MD52 Rx device
Amimon Inc.
MD52 Rx device - MDWL2_B3P1RX
In Commercial Distribution
- 00860014100673 ()
MDWL2_B3P1RX
- Medical image management system
MD52 Tx device
Amimon Inc.
MD52 Tx device - MDWL2_B1P1TX
In Commercial Distribution
- 00860014100666 ()
MDWL2_B1P1TX
- Medical image management system
MD11 Rx device
Amimon Inc.
MD11 Rx device - MDWL1_B1N1RX
In Commercial Distribution
- 00860014100635 ()
MDWL1_B1N1RX
- Medical image management system
MD11 Tx device
Amimon Inc.
MD11 Tx device - MDWL1_C1N1TX
In Commercial Distribution
- 00860014100628 ()
MDWL1_C1N1TX
- Medical image management system
MD62 Rx device
Amimon Inc.
MD62 Rx device - MDWL2_B1J1RX
In Commercial Distribution
- 00860014100611 ()
MDWL2_B1J1RX
- Medical image management system
MD62 Tx device
Amimon Inc.
MD62 Tx device - MDWL2_B1J1TX
In Commercial Distribution
- 00860014100604 ()
MDWL2_B1J1TX
- Medical image management system
Vascular Flow Analysis System
VASSOL, INC.
VS5060
In Commercial Distribution
- 00867170000106 ()
- MRI system application software
The Radlink GPS Tablet provides surgeons with real-time feedback on orthopedic implant component positioning. Together, the GPS Tablet and its Surgeon’s Checklist software offer easy-to-follow steps designed to address challenges such as component positioning, sizing, limb length and offset restoration. The Radlink GPS Tablet consists of a Tablet PC computer system that uses a touchscreen monitor & other image display accessories. Pre-operative images can be viewed on the GPS Tablet during surgery, which surgeons can use to reference against the intraoperative images captured during the procedure. For posterior approach THA procedures, a flat panel detector (DR panel) is used to capture intraoperative images, which takes approximately four seconds to appear on the GPS Tablet. For anterior approach THA procedures, C-Arm images are instantaneously transferred to the GPS Tablet using the Radlink Wireless C-Arm Kit.
RADLINK, INC.
TABLET
In Commercial Distribution
- 00866389000112 ()
- Radiology information system
The AS-OBGYN Information System is a PACS system that automates the managment of patient information. It is intended to be used by obstetricians, gynecologists, perinatologists, radiologists, and cardiologists.
Asw Software, LLC
10
In Commercial Distribution
- 00860010575307 ()
- Ultrasound imaging system application software
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-WB-001
In Commercial Distribution
- 00860006382322 ()
- 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
No Description
Analog Devices, Inc.
ADI-CS-200-001
In Commercial Distribution
- 00860006382308 ()
- Wearable multiple vital physiological parameter monitoring system
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
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
The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data.
CONVEXITY SCIENTIFIC LLC
700099
In Commercial Distribution
- 00860008932204 ()
- Wearable multiple vital physiological parameter monitoring system
STAGE is a MR post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE runs within a VM environment on hardware that meets the minimum requirements. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced T1 weighted images, SWI images, susceptibility enhanced images, pseudo-susceptibility maps, true SWI images, MR angiography (MRA) images, simulated T2 images, simulated T2 FLAIR images, simulated dual inversion recovery (DIR) images, and maps of T1, R2*, and proton density (PD). CROWN, introduced in STAGE, reduces noise some of these outputs, enhancing SNR and/or reducing imaging time. STAGE is indicated for brain imaging. Maximum and minimum intensity projections of some of these outputs will also be provided. The STAGE outputs can be configured to match the conventional acquisition series in MR protocols (i.e. routine brain w/) in terms of contrast, orientation and resolution.
STAGE should always be used in combination with at least one other conventional MR acquisition technique (e.g. T2 FLAIR). STAGE input data can be acquired within a range of collection parameters, within shorter echo acquisitions allowing for less susceptibility affects and higher anatomic signal at the air tissue interface or with longer echo times for higher susceptibility effects around blood products and iron sources.
Spintech, Inc.
2.3
In Commercial Distribution
- 00866463000465 ()
REF 200008
- MRI system application software
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client’s existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user’s current DICOM viewing software. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.
Spintech, Inc.
2
Not in Commercial Distribution
- 00866463000441 ()
- MRI system application software
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a dedicated computer connected to the user’s local area network. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e. the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to wherever it received the files from (most likely a PACS server). The STAGE system will not contain any user interface. Instead, the data transfer will be initiated by the user’s current DICOM viewing software. The main method for user communication will be through DICOM output files that contain information in the image data. A method for remote connection to the STAGE computer will be included for updating and troubleshooting when an internet connection is available.
Spintech, Inc.
1.1
Not in Commercial Distribution
- 00866463000410 ()
- MRI system application software
Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300
In Commercial Distribution
- 06938396423018 ()
- Portable basic diagnostic x-ray system, digital
No Description
EMPATICA SRL
Care Portal
In Commercial Distribution
- 00853858006263 ()
- Multiple vital physiological parameter monitoring system, home-use
No Description
EMPATICA SRL
Care App Android Version
In Commercial Distribution
- 00853858006256 ()
- Multiple vital physiological parameter monitoring system, home-use
No Description
EMPATICA SRL
Care App iOS
In Commercial Distribution
- 00853858006249 ()
- Multiple vital physiological parameter monitoring system, home-use