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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eRAD PACS Evolution
Erad, Inc.
8.0
In Commercial Distribution

  • 00866994000224 ()


  • Radiological PACS software
eRAD PACS v7.3
Erad, Inc.
7.3
In Commercial Distribution

  • 00866994000217 ()


  • Radiological PACS software
eRAD PACS v7.2
Erad, Inc.
7.2
In Commercial Distribution

  • 00866994000200 ()


  • Radiological PACS software
Standard Imaging PIPSpro Software is a stand alone software medical device used for QA checks of imaging systems used with radiation therapy systems.
STANDARD IMAGING INC.
v5
In Commercial Distribution

  • 00866562000236 ()
91309

  • Radiation therapy 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
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
A medical image software package that aids the physician in the diagnosis of patients by means of medical images. It is a DICOM viewer used to display, register and fuse medical images from multiple modalities for referring physicians.
MIM SOFTWARE INC.
3.8
Not in Commercial Distribution

  • 00865936000285 ()


  • Radiological PACS software
A medical imaging software package that provide imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging and cardiac imaging.
MIM SOFTWARE INC.
6.8
Not in Commercial Distribution

  • 00865936000278 ()


  • Radiological PACS software
A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging.
MIM SOFTWARE INC.
6.5
Not in Commercial Distribution

  • 00865936000254 ()


  • Radiological PACS software
A medical image software package that aids the physician in the diagnosis of patients by means of medical images. It is a DICOM viewer used to display, register and fuse medical images from multiple modalities for referring physicians.
MIM SOFTWARE INC.
3.7
Not in Commercial Distribution

  • 00865936000247 ()


  • Radiological PACS software
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