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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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Accuray Precision Treatment Planning System - 00811376030146

Accuray Precision™ Treatment Planning System (Version 3.1)
Accuray Incorporated
1070891
In Commercial Distribution

  • 00811376030146 ()
NA

  • Radiation therapy treatment planning workstation

Accuray Precision Treatment Planning System - 00811376030092

Accuray Precision™ Treatment Planning System (Version 3.0)
Accuray Incorporated
1063143
In Commercial Distribution

  • 00811376030092 ()
NA

  • Radiation therapy treatment planning workstation

4D VIEWER - RADIOLOGY, ULTRASOUND WORKSTATION PACKAGE - 04987670102370

4D VIEWER - RADIOLOGY, ULTRASOUND WORKSTATION PACKAGE
CANON MEDICAL SYSTEMS CORPORATION
USWP-100A
Not in Commercial Distribution

  • 04987670102370 ()


  • Ultrasound imaging system workstation

ULTRASOUND WORKSTATION PACKAGE - 04987670101014

ULTRASOUND WORKSTATION PACKAGE
CANON MEDICAL SYSTEMS CORPORATION
USWS-900A
In Commercial Distribution

  • 04987670101014 ()


  • Ultrasound imaging system workstation

ULTRASOUND WORKSTATION PACKAGE - 04987670100796

ULTRASOUND WORKSTATION PACKAGE
CANON MEDICAL SYSTEMS CORPORATION
TUW-U001S
In Commercial Distribution

  • 04987670100796 ()


  • Ultrasound imaging system workstation

ASPIRE Bellus II - 04547410345438

ASPIRE Bellus II is medical imaging software that is intended to provide trained medical imaging professionals, including Physicians and Radiologists, with tools to aid them in reading, interpreting, reporting. This product accepts DICOM compliant medical images acquired from a variety of imaging devices including, MG, CT, PT, MR, CR, DX, and US, etc. This product also provides general 2D/3D viewing and general image processing, measurements, annotations, reporting, printing, storing, and general image administration tools, etc.
FUJIFILM CORPORATION
MIS-1000
In Commercial Distribution

  • 04547410345438 ()


  • Radiology picture archiving and communication system workstation

Synapse 3D - 04547410324877

The product “Synapse 3D” is a system that receives and retrieves DICOM data from modalities including CT, MR, PET, XA, etc. and constructs 3D images and performs image analysis.
FUJIFILM CORPORATION
Synapse 3D
In Commercial Distribution

  • 04547410324877 ()


  • Radiology picture archiving and communication system workstation

Nio Color 3MP - 05415334001695

MDNC-3421 HLX
Barco NV
MDNC-3421
In Commercial Distribution

  • 05415334001695 ()
K9300345A

  • Radiology picture archiving and communication system workstation

Nio Color 3MP - 05415334001688

MDNC-3421 DE NC
Barco NV
MDNC-3421
In Commercial Distribution

  • 05415334001688 ()
K9300344A

  • Radiology picture archiving and communication system workstation

Coronis 5MP Mammo - 05415334001589

No Description
Barco NV
MDMG-5121
Not in Commercial Distribution

  • 05415334001589 ()
K9300508A

  • Radiology picture archiving and communication system workstation
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