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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 StructSure Software is designed to be used to assess the anatomical capabilities of: 1) clinical professionals who are responsible for contouring organs-at-risk and target volumes, i.e. manual contouring; and 2) automated contouring software systems, i.e. auto-segmentation.
STANDARD IMAGING INC.
91340
In Commercial Distribution

  • 00866562000281 ()
91340

  • Accelerator system quality assurance device
No Description
HELENA LABORATORIES CORPORATION
1691000
In Commercial Distribution

  • M52516910000 ()


  • Densitometry analyser IVD
EMAG software (virtual) version 1.4 also called SP4
BIOMERIEUX SA
1.4
In Commercial Distribution

  • 03573026635046 ()


  • Nucleic acid sample preparation instrument IVD
EMAG software (virtual) version 1.3 also called SP3
BIOMERIEUX SA
1.3
In Commercial Distribution

  • 03573026613358 ()


  • Nucleic acid sample preparation instrument IVD
Multi-exercise respiratory therapy device with OmniFlow software and sensor, and Synchrony software, electrodes, and sensing devices
ACCELERATED CARE PLUS CORP
100MTS
In Commercial Distribution

  • 00858703006320 ()


  • Bioelectrical signal analysis software
  • Biomechanical function analysis/interactive rehabilitation system
  • Monitoring spirometer, mechanical
PACSCore VNA archive with remote, remote backup, and optional local repositories, and ConnectWeb on remote archive
Radius
7
In Commercial Distribution

  • B295VNA70 ()


  • Radiological PACS software
Basic radiologist workstation
Radius
6
In Commercial Distribution

  • B295VBB60 ()


  • Radiological PACS software
ConnectWeb viewer front-end with PACSCore back-end archive
Radius
3
In Commercial Distribution

  • B295FULLPACS30 ()


  • Radiological PACS software
Advanced radiologist workstation
Radius
1
In Commercial Distribution

  • B295VBA10 ()


  • Radiological PACS software
Version >=3.0
STRYKER CORPORATION
521205090001
In Commercial Distribution

  • 07613327624328 ()
521205090001

  • Alarm application software
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