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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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Sectra Digital Pathology Module - 07350092810425

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

Sectra Digital Pathology Module - 07350092810388

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

Sectra Digital Pathology Module - 07350092810333

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

Sectra Digital Pathology Module - 07350092810289

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

Sectra Digital Pathology Module - 07350092810241

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

Sectra Digital Pathology Module - 07350092810197

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

NA - M65810604640

Software, TomoApps, Version 5.1.2 Operating Software for TomoTherapy systems (including TomoH®, TomoHD®, TomoHDA) and Onrad Treatment System™
ACCURAY INCORPORATED
1060464
In Commercial Distribution

  • M65810604640 ()
NA

  • Linear accelerator system

Tobii Dynavox - 07340074601042

Speech Generating Device with a 7" screen on Windows platform. Tobii Dynavox software includes Snap+Corefirst, Compass or Communicator software.
TOBII DYNAVOX LLC
Indi 7
Not in Commercial Distribution

  • 07340074601042 ()
750518

  • Voice synthesizer/digitizer

Roentgen Works - 00850631008247

Roentgen Works 4.1.1
Brit Systems, LLC
4.1.1
In Commercial Distribution

  • 00850631008247 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software

Roentgen Works - 00850631008230

Roentgen Works 4.1.0
Brit Systems, LLC
4.1.0
In Commercial Distribution

  • 00850631008230 ()


  • Radiological PACS software
  • Radiology information system application software
  • Radiology DICOM image processing application software
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