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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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ELI Edit - 00817655022802

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-51
In Commercial Distribution

  • 00817655022802 ()


  • Patient health record information system

ELI Edit - 00817655022796

Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-011-50
In Commercial Distribution

  • 00817655022796 ()


  • Patient health record information system

E-Scribe - 00817655021270

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESWKST-BAA-BXXXX
Not in Commercial Distribution

  • 00817655021270 ()


  • Patient health record information system

E-Scribe - 00817655020617

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-CAA-DAACA
Not in Commercial Distribution

  • 00817655020617 ()


  • Patient health record information system

Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad - 00817100020490

Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPAL 02-04-06-000
In Commercial Distribution

  • 00817100020490 ()


  • Diagnostic x-ray digital imaging system workstation

Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad - 00817100020209

Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPAL 02-04-04-000
In Commercial Distribution

  • 00817100020209 ()


  • Diagnostic x-ray digital imaging system workstation

Konica Minolta SW (PACS) Exa - 00817100020193

EXA is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
EXA 01-04-000
In Commercial Distribution

  • 00817100020193 ()


  • Diagnostic x-ray digital imaging system workstation

E-Scribe - 00812345027785

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESWKST-FAA-BXXXX
Not in Commercial Distribution

  • 00812345027785 ()


  • Patient health record information system

E-Scribe - 00812345027778

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESWKST-EAA-BXXXX
Not in Commercial Distribution

  • 00812345027778 ()


  • Patient health record information system

E-Scribe - 00812345027761

Cardiology Data Management System
MORTARA INSTRUMENT, INC.
ESCRIBE-CAA-CXACB
Not in Commercial Distribution

  • 00812345027761 ()


  • Patient health record information system
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