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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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Standard Imaging QA Pilot is cloud-based software tool that allows users to enter, store, and analyze data accumulated in the clinical radiation oncology setting from quality assurance processes.
STANDARD IMAGING INC.
91348
In Commercial Distribution

  • 00866562000298 ()
91348

  • Radiation therapy software
Standard Imaging Adaptivo Software is a stand alone software medical device used for QA checks of comparative and cumulative dose received during radiation treatment from radiation therapy systems.
STANDARD IMAGING INC.
v1
In Commercial Distribution

  • 00866562000243 ()
91350

  • Radiation therapy software
Standard Imaging IMSure QA Software is a stand alone software medical device used for monitor unit secondary checks and IMRT treatment plan secondary checks of radiation treatment plans from radiation therapy systems.
STANDARD IMAGING INC.
v3
In Commercial Distribution

  • 00866562000229 ()
91326

  • Radiation therapy software
The Radiation Analyzer (RAy)is a film dosimetry application used to verify complex radiation therapy treatment plans.
AGILE RADIOLOGICAL TECHNOLOGIES
5.0
Not in Commercial Distribution

  • 00866498000300 ()
Ray 5.0

  • Radiation therapy software
Final software release for UDI-DI: T-2022.03. Simpleware ScanIP Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as pre-operative software for diagnostic and surgical planning. For these purposes, output files can also be used for the fabrication of physical replicas using traditional or additive manufacturing methods. The physical replicas can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. The software is intended to be used in conjunction with other diagnostic tools and expert clinical judgment.
SYNOPSYS, INC.
S-2021.06 onwards
Not in Commercial Distribution

  • 00863520000390 ()


  • Radiological PACS software
No Description
SYNOPSYS, INC.
R-2021.03
Not in Commercial Distribution

  • 00863520000383 ()


  • Radiological PACS software
No Description
SYNOPSYS, INC.
R-2020.09
Not in Commercial Distribution

  • 00863520000376 ()


  • Radiological PACS software
No Description
SYNOPSYS, INC.
Q-2020.03
Not in Commercial Distribution

  • 00863520000369 ()


  • Radiological PACS software
No Description
SYNOPSYS, INC.
Q-2020.06
Not in Commercial Distribution

  • 00863520000352 ()


  • Radiological PACS software
No Description
SYNOPSYS, INC.
P-2019.09
Not in Commercial Distribution

  • 00863520000345 ()


  • Radiological PACS software
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