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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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INTERSON CORP
x.x
In Commercial Distribution

  • 00850921007202 ()


  • General-purpose ultrasound imaging system
User interface in the patient's room
Vital Connect, Inc.
6100-03
In Commercial Distribution

  • 00850490007382 ()
6100-03

  • Electrocardiography telemetric monitoring system
User interface in the patient's room
Vital Connect, Inc.
6100-01
In Commercial Distribution

  • 00850490007160 ()
6100-01

  • Electrocardiography telemetric monitoring system
Guideline 4000™ Resident Expert Software Module, 1x
FHC, INC.
C0258-00818
In Commercial Distribution

  • 00873263008188 ()
C0258

  • Neurophysiologic monitoring system
Guideline 4000™ Resident Expert Software Module, 1x
FHC, INC.
C0258-00808
Not in Commercial Distribution

  • 00873263008089 ()
C0258

  • Neurological stereotactic surgery system
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
E-LINK is a computerized modular system bringing both evaluation and exercise together in an exciting format with an extensive scope of clinical applications for the upper and lower extremities. E-LINK is available in English, Chinese, German and Spanish.
BIOMETRICS LIMITED
16xx-xxx-xxxx
In Commercial Distribution

  • 05060481690454 ()


  • Biomechanical function analysis/rehabilitation software
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