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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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NEUROWORKS/SLEEPWORKS 8.1.0 DVD (INTL)  
XLTEK
015447
In Commercial Distribution

  • 00382830042123 ()


  • Electroencephalograph
EP WORKS for Protektor(16) DVD
XLTEK
007134
In Commercial Distribution

  • 00382830041904 ()


  • Electroencephalograph
Neonatal Sensors
XLTEK
CZA00037
In Commercial Distribution

  • 00382830007443 ()
  • 00382830058506 ()


  • Analytical scalp electrode, single-use
Neuroworks Sleepworks 6.1 DVD  
XLTEK
005523
In Commercial Distribution

  • 00382830041898 ()


  • Electroencephalograph
Electrode junction box (256 channel)
NIHON KOHDEN AMERICA, INC.
JE-120A-24
In Commercial Distribution

  • 00841983100659 ()
JE-120A-24

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

  • 00841983100642 ()
JE-120A-23

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

  • 00841983100635 ()
JE-120A-22

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

  • 00841983100628 ()
JE-120A-21

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

  • 00195278560384 ()
5919805

  • CT system application software
BASE UNIT, JE-120A
NIHON KOHDEN AMERICA, INC.
QI-123A
In Commercial Distribution

  • 00841983102592 ()
QI-123A

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

  • 00841983101199 ()
QI-124A

  • Electroencephalograph
No Description
Siemens Healthcare GmbH
11823875
In Commercial Distribution

  • 04068151010404 ()


  • Radiology DICOM image processing application software
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
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
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
It is used by radiation oncology department to register multimodality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation.
Manteia Technologies Co.,Ltd.
1.1.0
In Commercial Distribution

  • 16973127400019 ()
  • 06973127400012 ()


  • Radiology DICOM image processing application software
PRODUCT SFTWR MMT-7333WW PERSONAL 15.1A
MEDTRONIC MINIMED, INC.
MMT-7333WW
In Commercial Distribution

  • 00763000984755 ()


  • Self-care monitoring/reporting software
PRODUCT SFTWR MMT-7333WW PERSONAL 14.13A
MEDTRONIC MINIMED, INC.
MMT-7333WW
In Commercial Distribution

  • 00763000424121 ()


  • Self-care monitoring/reporting software
For In Vitro Diagnostic Use Sectra Digital Pathology Module (3.3) is a software device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module (3.3) is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module (3.3) is intended for use with Leica’s Aperio GT 450 DX scanner and Dell U3223QE display, for viewing and management of the ScanScope Virtual Slide (SVS) and Digital Imaging and Communications in Medicine (DICOM) image formats.
Sectra AB
4.2
In Commercial Distribution

  • 07350092810593 ()


  • Pathology information system
For In Vitro Diagnostic Use Sectra Digital Pathology Module (3.3) is a software device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module (3.3) is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module (3.3) is intended for use with Leica’s Aperio GT 450 DX scanner and Dell U3223QE display, for viewing and management of the ScanScope Virtual Slide (SVS) and Digital Imaging and Communications in Medicine (DICOM) image formats.
Sectra AB
4.1
In Commercial Distribution

  • 07350092810524 ()


  • Pathology information system
For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
4.0
In Commercial Distribution

  • 07350092810500 ()


  • Pathology information system
For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
3.4
In Commercial Distribution

  • 07350092810487 ()


  • Pathology information system
For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
3.3
In Commercial Distribution

  • 07350092810456 ()


  • Pathology information system
For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
3.2
In Commercial Distribution

  • 07350092810425 ()


  • Pathology information system
For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
3.1
In Commercial Distribution

  • 07350092810388 ()


  • Pathology information system
For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
2.5
In Commercial Distribution

  • 07350092810333 ()


  • Pathology information system
For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
2.4
In Commercial Distribution

  • 07350092810289 ()


  • Pathology information system
For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
2.3
In Commercial Distribution

  • 07350092810241 ()


  • Pathology information system
For In Vitro Diagnostic Use Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra AB
2.2
In Commercial Distribution

  • 07350092810197 ()


  • Pathology information system
HeartVista Cardiac Package
Heartvista, Inc.
030004
Not in Commercial Distribution

  • B440HVCP030 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software
HeartVista Cardiac Package
Heartvista, Inc.
020301
In Commercial Distribution

  • B440HVCP020 ()
HVCP

  • MRI system operator console
  • MRI system operation software
  • MRI system application software
No Description
Icad, Inc.
DSC012-02
In Commercial Distribution

  • 00850008977183 ()


  • Basic diagnostic x-ray system application software
No Description
Icad, Inc.
DSC012-03
In Commercial Distribution

  • 00850008977190 ()


  • Basic diagnostic x-ray system application software
No Description
Icad, Inc.
3.0
In Commercial Distribution

  • 00850008977176 ()


  • Basic diagnostic x-ray system application software
PROG 8835 PERSONAL THERAPY 60601-11
MEDTRONIC, INC.
8835
In Commercial Distribution

  • 00643169512948 ()


  • Infusion pump programmer
PROG 8835 PERSONAL THERAPY MGR ROHS
MEDTRONIC, INC.
8835
In Commercial Distribution

  • 00643169518957 ()


  • Infusion pump programmer
PROGRAMMER 8835 PERSONAL THERAPY
MEDTRONIC, INC.
8835
In Commercial Distribution

  • 00613994338754 ()


  • Infusion pump programmer
No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026982 ()


  • Basic diagnostic x-ray system application software
No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026975 ()


  • Basic diagnostic x-ray system application software
No Description
J.MORITA MFG.CORP.
i-Dixel
In Commercial Distribution

  • 04548213026968 ()


  • Basic diagnostic x-ray system application software
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