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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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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
No Description
EMPATICA SRL
EmbracePlus
In Commercial Distribution

  • 00853858006232 ()
EMBP-CC-MS

  • Multiple vital physiological parameter monitoring system, home-use
No Description
Sira Medical, Inc.
1
In Commercial Distribution

  • G67910 ()


  • Surgical planning/navigation-enhancement system
VX-100 is a battery-operated, portable X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The VX-100 is designed for use in general-purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. Because of its low power output, the CLAROX plus (Model VX-100) is intended for exclusive use on body extremities. The functions of the VX-100 handheld system are supported by software (firmware).
VSI Co., Ltd.
VX-100
In Commercial Distribution

  • 18800124900014 ()
  • 08800124900017 ()


  • Portable basic diagnostic x-ray system, digital
CARESCAPE CENTRAL STATION V1 UPGRADE KIT FROM CIC V5 ON MP100
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Central Station v1 upgrade
Not in Commercial Distribution

  • 00840682109833 ()


  • Centralized patient monitor
ASSY CSCS V1 MP100D DESKTOP
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Central Station v1
Not in Commercial Distribution

  • 00840682109826 ()


  • Centralized patient monitor
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