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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Vitegra®3 IO-Modul Image/Video Capture
Joimax GmbH
ICS1900IO
In Commercial Distribution

  • 04250337106364 ()
ICS1900IO

  • Medical image management system
joimax® Vitegra® Wireless Microphone Set
Joimax GmbH
ICWSR400
In Commercial Distribution

  • 04250337105312 ()
ICWSR400

  • Medical image management system
joimax® Rotate and Slope Adaptor for Vitegra®
Joimax GmbH
ICRA410G
In Commercial Distribution

  • 04250337105299 ()
ICRA410G

  • Medical image management system
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
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
The Humero Tech C1 HD is an updated version of the Humero Tech C1 to better withstand strength and conditioning activities in addition to rehabilitation. The C1 HD is a seated apparatus capable of completing a vast number of shoulder rehabilitation and strengthening exercises. This device has the capability to be utilized in low level rehabilitation and strengthening progressing to more functional and dynamic activities. The Humero Tech C1 HD has an intended us of assisting with improving the strength, active range of motion, and motor control of the postoperative status, or when a deficit in power is noted. The device collects data and tracks range of motion to evaluate progress over time.
Titin Km Biomedical Corp.
C1 HD
In Commercial Distribution

  • 00860010519912 ()
A2-0000

  • Virtual-display rehabilitation system, passive-support, upper-limb
The Humero Tech C1 has been developed as a solution for the current limitations with shoulder rehabilitation. The C1 is a seated apparatus capable of completing a vast number of shoulder rehabilitation and strengthening exercises. This device has the capability to be utilized in low level rehabilitation and strengthening progressing to more functional and dynamic activities. The Humero Tech C1 has an intended use of assisting with improving the strength, active range of motion, and motor control of the shoulder complex. Furthermore, the indications for use will be any individual suffering from a shoulder pathology, including postoperative status, or when a deficit in power is noted. The device collects data and tracks range of motion to evaluate progress over time.
Titin Km Biomedical Corp.
C1
In Commercial Distribution

  • 00860010519905 ()
A1-0000

  • Virtual-display rehabilitation system, passive-support, upper-limb
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