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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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WorkstationOne™ - B148WSONE1850

WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.5
In Commercial Distribution

  • B148WSONE1850 ()


  • Radiology picture archiving and communication system workstation

WorkstationOne™ - B148WSONE1840

WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.4
In Commercial Distribution

  • B148WSONE1840 ()


  • Radiology picture archiving and communication system workstation

WorkstationOne™ - B148WSONE1830

WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.3
In Commercial Distribution

  • B148WSONE1830 ()


  • Radiology picture archiving and communication system workstation

WorkstationOne™ - B148WSONE1820

WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.2
In Commercial Distribution

  • B148WSONE1820 ()


  • Radiology picture archiving and communication system workstation

WorkstationOne™ - B148WSONE1810

WorkstationOne is a vendor-neutral diagnostic breast imaging workstation which consists of a software system that obtains breast imaging screening or diagnosis exams from PACS (Picture Archiving and Communication System) or Modalities; displays and manipulates the images for radiologists to perform interpretation task. The workstation can also interface with a reporting system to generate an interpretation report. Optionally, the workstation supports media exchange and film printing.
THREE PALM SOFTWARE
1.8.1
In Commercial Distribution

  • B148WSONE1810 ()


  • Radiology picture archiving and communication system workstation

QCT PRO Asynchronous 3D Spine and CTXA-Hip System - B052QCTPROM4ASH0

Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 4 Calibration Phantom
MINDWAYS SOFTWARE, INC.
K894854K002113K030330K140342
In Commercial Distribution

  • B052QCTPROM4ASH0 ()
  • QCTPROM4ASHN0100 ()
  • QCTPROM4ASHN0075 ()
  • QCTPROM4ASHN0050 ()
  • QCTPROM4ASHN0025 ()
  • QCTPROM4ASHN0010 ()
  • QCTPROM4ASHN0005 ()
  • QCTPROM4ASHN0003 ()
  • QCTPROM4ASHN0002 ()
  • QCTPROM4ASHN0500 ()
  • QCTPROM4ASHN0200 ()
QCTPROM4ASH

  • CT system application software

QCT PRO 3D Volumetric Spine and CTXA Hip System - B052QCTPROM3SSH0

Convenience Kit consisting of - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 3 QA & Calibration Phantom Set
MINDWAYS SOFTWARE, INC.
K894854K002113K030330
In Commercial Distribution

  • B052QCTPROM3SSH0 ()
QCTPROM3SSH

  • CT system application software

QCT PRO 3D Volumetric Spine System - B052QCTPROM3SS0

Convenience Kit consisting of - QCT Bone Mineral Density Analysis Software, - Model 3 QA & Calibration Phantom Set and - Accessories.
MINDWAYS SOFTWARE, INC.
K894854
In Commercial Distribution

  • B052QCTPROM3SS0 ()
QCTPROM3SS

  • CT system application software

QCT PRO Asynchronous 3D Spine and CTXA-Hip System - B052QCTPROM3ASH0

Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 3 QA & Calibration Phantom Set
MINDWAYS SOFTWARE, INC.
K894854K002113K030330K140342
In Commercial Distribution

  • B052QCTPROM3ASH0 ()
QCTPROM3ASH

  • CT system application software

QCT PRO 3D Volumetric Spine Software - B052QCTPROM0SS0

Convenience Kit consisting of - QCT Bone Mineral Density Analysis Software - Accessories
MINDWAYS SOFTWARE, INC.
K894854
In Commercial Distribution

  • B052QCTPROM0SS0 ()
QCTPROM0SS

  • CT system application software
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