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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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Captus 4000e Thyroid Uptake System - 00859942006096

The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module.
Mirion Technologies (capintec), Inc.
Captus 4000e Thyroid Uptake System
In Commercial Distribution

  • 00859942006096 ()
5430-30151

  • Thyroid-uptake nuclear medicine system

SMILE-100 System - 08908019450057

The SMILE-100 System is a breast thermography device with a visualization tool that helps a healthcare personnel to review, measure and analyze thermally significant indications in the breast region. It is intended to be used in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or an environment where patient care is provided by qualified healthcare personnel.
NIRAMAI HEALTH ANALYTIX PRIVATE LIMITED
v4.8.0
In Commercial Distribution

  • 08908019450057 ()
NA

  • Infrared thermography interpretive software

VISIUSmatrix - 00857534006639

Applications Platform 4.0 US/JPN – INT KIT-120085-000
IMRIS Imaging, Inc.
Application Platform 4.0- KIT
In Commercial Distribution

  • 00857534006639 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006622

Applications Platform 4.0 US/JPN – 3 Room- 119897-000
IMRIS Imaging, Inc.
Application Platform 4.0- 3 Room
In Commercial Distribution

  • 00857534006622 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006493

Applications Platform 4.0 NA/JAPAN 2-Room- 119407-000
IMRIS Imaging, Inc.
Application Platform 4.0 2-Room
In Commercial Distribution

  • 00857534006493 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006363

Application Platform 2.4 NA
IMRIS Imaging, Inc.
115407-000
In Commercial Distribution

  • 00857534006363 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006684

Applications Platform 4.0 INTL – INT KIT – 3 Room
IMRIS Imaging, Inc.
120088-000
In Commercial Distribution

  • 00857534006684 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006677

Applications Platform 4.0 INTL – INT KIT
IMRIS Imaging, Inc.
120086-000
In Commercial Distribution

  • 00857534006677 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006660

Applications Platform 4.0 INTL – 3 Room
IMRIS Imaging, Inc.
119898-000
In Commercial Distribution

  • 00857534006660 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006653

Applications Platform 4.0-INTL-2-Room
IMRIS Imaging, Inc.
119408-000
In Commercial Distribution

  • 00857534006653 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system
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