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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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FONA CDR DICOM 4.5 SOFTWARE - MULTI USER (ENGLISH)
SIRONA DENTAL, INC.
B1035106
In Commercial Distribution

  • D764B10351060 ()


  • Diagnostic x-ray digital imaging system workstation application software
CDR DICOM 5.0 FOR WINDOWS SOFTWARE
SIRONA DENTAL, INC.
B1030191
In Commercial Distribution

  • D764B10301910 ()


  • Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-02-04-00-000
In Commercial Distribution

  • 00817100020438 ()


  • Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-02-03-04-000
In Commercial Distribution

  • 00817100020421 ()


  • Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-04-01-00-000
In Commercial Distribution

  • 00817100020414 ()


  • Diagnostic x-ray digital imaging system workstation application software
ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
ULTRA 04-01-00-000
In Commercial Distribution

  • 00817100020407 ()


  • Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ 04-02-01-000
In Commercial Distribution

  • 00817100020186 ()


  • Diagnostic x-ray digital imaging system workstation application software
ViZion Ultra is intended for digital image capture use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. ViZion Ultra allows imaging of the skull, chest, shoulders, spine, abdomen, pelvis, and extremities.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
ULTRA 04-02-01-000
In Commercial Distribution

  • 00817100020179 ()


  • Diagnostic x-ray digital imaging system workstation application software
ARTHROVAC, FELT PADS (10-BOX)
ARTHREX, INC.
AR-4004P
In Commercial Distribution

  • 00888867031111 ()
  • 10888867031118 ()
AR-4004P

  • Decontamination floor mat, single-use
Software for analysis of echocardiogram
EPSILON IMAGING
3.2.0
Not in Commercial Distribution

  • B557ECHOINSIGHT0 ()


  • Cardiac mapping system application software
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