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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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Xmaru PACS - 08800018600429

Xmaru PACS is a software program designed to provide image acquisition, processing and operational management functions for Digital Radiography.
Rayence Co., Ltd.
Xmaru PACS
In Commercial Distribution

  • 08800018600429 ()


  • Basic diagnostic x-ray system application software

XmaruView V1 - 08800018600399

XmaruView V1 is a radiographic image acquisition and image data management program in charge of variety of image related functions, including photographing Digital Radiography, acquiring and processing the images, and the image management
Rayence Co., Ltd.
XmaruView V1
In Commercial Distribution

  • 08800018600399 ()


  • Basic diagnostic x-ray system application software

MAR - 00840682134989

No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution

  • 00840682134989 ()


  • CT system application software

ASiR-V - 00840682134972

No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution

  • 00840682134972 ()


  • CT system application software

Proteus - 00840682120777

PDU COMPONENT ASSEMBLE
GE Hualun Medical Systems Co., Ltd
XRa
In Commercial Distribution

  • 00840682120777 ()


  • Stationary basic diagnostic x-ray system, analogue

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
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