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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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NA - 00841983100642

Electrode junction box (192 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A-23
In Commercial Distribution

  • 00841983100642 ()
JE-120A-23

  • Electroencephalograph

NA - 00841983100635

Electrode junction box (128 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A-22
In Commercial Distribution

  • 00841983100635 ()
JE-120A-22

  • Electroencephalograph

NA - 00841983100628

Electrode junction box (64 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A
In Commercial Distribution

  • 00841983100628 ()
JE-120A-21

  • Electroencephalograph

Auto Segmentation - 00195278560384

MD Auto Segmentation for Smart Subscription
GE MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00195278560384 ()
5919805

  • CT system application software

NA - 00841983102592

BASE UNIT, JE-120A
NIHON KOHDEN AMERICA, INC.
QI-123A
In Commercial Distribution

  • 00841983102592 ()
QI-123A

  • Electroencephalograph

NA - 00841983101199

EXTENDED LAN UNIT, JE-120A
NIHON KOHDEN AMERICA, INC.
QI-124A
In Commercial Distribution

  • 00841983101199 ()
QI-124A

  • Electroencephalograph

AI-Rad Companion Organs RT - 04068151010404

No Description
Siemens Healthcare GmbH
11823875
In Commercial Distribution

  • 04068151010404 ()


  • Radiology DICOM image processing application software

RT-Mind-AI - 06975191150008

It is used by radiation oncology department to segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.
MedMind Technology Co., Ltd.
V1
In Commercial Distribution

  • 06975191150008 ()


  • Radiology DICOM image processing application software

AccuContour - 06973127400050

It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.
Manteia Technologies Co.,Ltd.
3.1.0
In Commercial Distribution

  • 06973127400050 ()


  • Radiology DICOM image processing application software

AccuContour - 06973127400029

It is used by radiation oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.
Manteia Technologies Co.,Ltd.
AccuContour
Not in Commercial Distribution



  • Radiology DICOM image processing application software
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