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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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Compass International - B169SOFTWARE0

Software Maintenance Contract
Compass International
SOFTWARE
In Commercial Distribution

  • B169SOFTWARE0 ()
SOFTWARE

  • Stereotactic system application software

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 and CTXA Hip Software - B052QCTPROM0SSH0

Convenience Kit consisting of - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database
MINDWAYS SOFTWARE, INC.
K894854K002113K030330
In Commercial Distribution

  • B052QCTPROM0SSH0 ()
QCTPROM0SSH

  • 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

QCT PRO Asynchronous 3D Spine and CTXA-Hip Software - B052QCTPROM0ASH0

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
MINDWAYS SOFTWARE, INC.
K894854K002113K030330K140342
In Commercial Distribution

  • B052QCTPROM0ASH0 ()
QCTPROM0ASH

  • CT system application software

QCT PRO Asynchronous 3D Spine Software - B052QCTPROM0AS0

Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - Accessories
MINDWAYS SOFTWARE, INC.
K894854K140342
In Commercial Distribution

  • B052QCTPROM0AS0 ()
QCTPROM0AS

  • CT system application software

Model 4 CT Calibration Phantom - B052PHCTM40

Calibration phantom intended for use as an accessory to the QCT Pro Bone Mineral Densitometry Software.
MINDWAYS SOFTWARE, INC.
4
In Commercial Distribution

  • B052PHCTM40 ()


  • Bone densitometry x-ray phantom, test object
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