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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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No Description
MEDSPIRA, LLC
RMD-002-001
In Commercial Distribution

  • 00851607003211 ()


  • Manometric gastrointestinal motility analysis system
No Description
MEDSPIRA, LLC
RMD-001-003
In Commercial Distribution

  • 00851607003204 ()


  • Manometric gastrointestinal motility analysis system
A comprehensive analysis suite for magnetoencephalographic and electroencephalographic data acquired with Elekta Neuromag®, Elekta Neuromag® TRIUX and TRIUX™ neo.
Megin Oy
SW23380N
In Commercial Distribution

  • 06430056480022 ()


  • Electroencephalograph
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
Standard Imaging RAy Software is a film dosimetry application, designed to perform one-dimensional, two-dimensional, and three-dimensional analyses of dose deposition pattern on film under specific mega-voltage irradiation setups.
STANDARD IMAGING INC.
91336
In Commercial Distribution

  • 00866562000274 ()
91336

  • Radiation therapy software
Standard Imaging LinacView Software is a stand alone software medical device used for logfile analysis of radiation therapy systems.
STANDARD IMAGING INC.
91330
In Commercial Distribution

  • 00866562000267 ()
91330

  • Radiation therapy 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
No Description
Philips Ultrasound LLC
989605496481
In Commercial Distribution

  • 00884838091672 ()


  • Radiological PACS software
No Description
Philips Ultrasound LLC
989605492681
In Commercial Distribution

  • 00884838090736 ()


  • Radiological PACS software
No Description
Philips Ultrasound LLC
989605465051
In Commercial Distribution

  • 00884838084322 ()


  • Radiological PACS software
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