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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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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
Leksell GammaPlan
Elekta Solutions AB
1567714
In Commercial Distribution

  • 07340201502136 ()


  • Stereotactic system application software
Leksell GammaPlan
Elekta Instrument AB
1551287
In Commercial Distribution

  • 07340048311878 ()


  • Stereotactic system application software
LGP 11.1
Elekta Instrument AB
1529980
In Commercial Distribution

  • 07340048311236 ()


  • Stereotactic system application software
LGP 11.1 SW MEDIA
Elekta Instrument AB
1529604
Not in Commercial Distribution

  • 07340048311229 ()
1529980

  • Stereotactic system application software
No Description
Change Healthcare Canada Company
15.1.1
In Commercial Distribution

  • 17540262090147 ()


  • Cardiology information system
No Description
Change Healthcare Canada Company
15.1
In Commercial Distribution

  • 17540262090130 ()


  • Cardiology information system
No Description
Change Healthcare Canada Company
15.0.1
In Commercial Distribution

  • 17540262090116 ()


  • Cardiology information system
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