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Central Hub Speaker
Sibel Health Inc.
900-00004
In Commercial Distribution
- 00850064210194 ()
- Wearable multiple vital physiological parameter monitor
Central Hub CMS
Sibel Health Inc.
900-00013
In Commercial Distribution
- 00850064210163 ()
- Wearable multiple vital physiological parameter monitor
Patient monitor consisting of a mobile tablet and the ANNE View software. The ANNE View Patient Monitor connects to the ANNE Chest sensor, ANNE Limb sensor, and compatible devices for the real-time display of physiological data.
Sibel Health Inc.
900-00012
In Commercial Distribution
- 00850064210132 ()
- Wearable multiple vital physiological parameter monitor
Box of 30 7-Day adhesives for the ANNE Chest sensor.
Sibel Health Inc.
900-00010
In Commercial Distribution
- 00850064210101 ()
- Wearable multiple vital physiological parameter monitor
Bedside charger for the ANNE Chest and ANNE Limb sensors.
Sibel Health Inc.
900-00008
In Commercial Distribution
- 00850064210057 ()
- Wearable multiple vital physiological parameter monitor
Pouch of 10 1-Day adhesives for the ANNE Chest sensor.
Sibel Health Inc.
900-00014
In Commercial Distribution
- 00850064210026 ()
- Wearable multiple vital physiological parameter monitor
Pouch of 5 7-Day Adhesives for the ANNE Chest sensor.
Sibel Health Inc.
900-00038
In Commercial Distribution
- 00850064210019 ()
- Wearable multiple vital physiological parameter monitor
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.
900-00007
In Commercial Distribution
- 00850064210002 ()
- Wearable multiple vital physiological parameter monitor
TIMS Streamer transmits any live medical modality video over networks - LAN, WAN, VPN, and Internet. Provides secure, encrypted and HIPPA Compliant information. Usage includes live training, mentoring, proctoring and monitoring. Functionality includes recording segments and entire procedures.
FORESIGHT IMAGING, LLC
TIMS Streamer 1B
Not in Commercial Distribution
- 00850951007265 ()
072000-100
- Medical image management system
TIMS Streamer transmits any live medical modality video over networks - LAN, WAN, VPN, and Internet. Provides secure, encrypted and HIPPA Compliant information. Usage includes live training, mentoring, proctoring and monitoring. Functionality includes recording segments and entire procedures.
FORESIGHT IMAGING, LLC
TIMS Streamer 1A
Not in Commercial Distribution
- 00850951007036 ()
072000-100
- Medical image management system
The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-XN0E0
In Commercial Distribution
- 00851920007248 ()
01-02-1019
- Multiple vital physiological parameter monitoring system, clinical
The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-XNAE0
In Commercial Distribution
- 00851920007231 ()
01-02-1023
- Multiple vital physiological parameter monitoring system, clinical
The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-XMAE0
In Commercial Distribution
- 00851920007156 ()
01-02-1022
- Multiple vital physiological parameter monitoring system, clinical
The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
ZOE MEDICAL INCORPORATED
740 SELECT-XMFE0
In Commercial Distribution
- 00851920007149 ()
01-02-1020
- Multiple vital physiological parameter monitoring system, clinical
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
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