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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 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
The Surgical Light Control and Surgical Camera Control for the Harmony IQ 3600 Integration Systems promotes efficient and prompt reaction to procedure events.
BLACK DIAMOND VIDEO, INC.
Harmony iQ 3600
Not in Commercial Distribution

  • 00724995199142 ()
RLQ3600SLC

  • Operating room audiovisual data/device management system application software
The Surgical Light Control and Surgical Camera Control for the Harmony IQ 2800 Integration Systems promotes efficient and prompt reaction to procedure events.
BLACK DIAMOND VIDEO, INC.
Harmony iQ 2800
Not in Commercial Distribution

  • 00724995199135 ()
RLQ2000SLC

  • Operating room audiovisual data/device management system application software
The HexaVue Integration System with Surgical Light Control is a scalable and flexible OR Integration System that can be used in the operating room for the purpose of video routing, conferencing, streaming, recording and can accept SD, HD and 4K signals.
BLACK DIAMOND VIDEO, INC.
HexaVue-SLC 1.0
In Commercial Distribution

  • 00724995198497 ()
XQHLC1

  • Operating room audiovisual data/device management system application software
No Description
GE Vingmed Ultrasound AS
Plug-in v201
In Commercial Distribution

  • 00840682104333 ()


  • Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Software Only v201
In Commercial Distribution

  • 00840682103961 ()


  • Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Plug-in v202
In Commercial Distribution

  • 00840682123518 ()


  • Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Software Only v202
In Commercial Distribution

  • 00840682123501 ()


  • Ultrasound imaging system application software
No Description
GE Vingmed Ultrasound AS
Software Only v113
In Commercial Distribution

  • 00840682121095 ()


  • Ultrasound imaging system application software
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