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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ClearON Mobile provides easy touch based user interface to perform diagnosis of digital radiograph images displayed on ClearOn Mobile. ClearON Mobile receives digital images from a flat panel detector and a X-ray generator. The software also manages patient data, stores and transfers diagnostic images in an internal database.  It supports DICOM image file format which allows interoperability with other Radiography equipment in network environment.  
Rayence Co., Ltd.
ClearON Mobile
In Commercial Distribution

  • 08800018600573 ()


  • Basic diagnostic x-ray system application software
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 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
No Description
GENORAY CO., LTD.
Triana
In Commercial Distribution

  • 08809244060144 ()


  • General-purpose dental x-ray system application software
The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database.
JPI HEALTHCARE. CO., LTD.
ExamVue PACS
In Commercial Distribution

  • 08809413810174 ()


  • Basic diagnostic x-ray system application software
The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue DR software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol.
JPI HEALTHCARE. CO., LTD.
ExamVue DR
In Commercial Distribution

  • 08809413810143 ()


  • Basic diagnostic x-ray system application software
Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW300 ()
XDRSW30

  • General-purpose dental x-ray system application software
Dental imaging software
CYBER MEDICAL IMAGING, INC.
Imaging Software
In Commercial Distribution

  • D787XDRSW1 ()
XDRSW

  • General-purpose dental x-ray system application software
Monarch Software Laptop v2.2.1
AURIS HEALTH, INC.
Version 2.2.1
In Commercial Distribution

  • B634SW0121940202000 ()


  • CT system application software
Monarch Software Laptop v2.1.6
AURIS HEALTH, INC.
Version 2.1.6
In Commercial Distribution

  • B634SW0121900201060 ()


  • CT system application software
Monarch™ Software Laptop v2.1.5
AURIS HEALTH, INC.
Version 2.1.5
In Commercial Distribution

  • B634SW0032760201050 ()


  • CT system application software
Monarch™ Software Laptop v2.1.4
AURIS HEALTH, INC.
Version 2.1.4
In Commercial Distribution

  • B634SW0032760201040 ()


  • CT system application software
Monarch™ Software Laptop v2.1.3
AURIS HEALTH, INC.
Version 2.1.3
In Commercial Distribution

  • B634SW0032760201030 ()


  • CT system application software
Monarch™ Software Laptop v2.1.2
AURIS HEALTH, INC.
Version 2.1.2
In Commercial Distribution

  • B634SW0032760201020 ()


  • CT system application software
Ablation Planning Application
Covidien LP
CAMPA
Not in Commercial Distribution

  • 10884521214026 ()


  • CT system application software
VATS Planning Application
Covidien LP
CAMPV
Not in Commercial Distribution

  • 10884521214019 ()


  • CT system application software
Procedure Planning Application
Covidien LP
CAMPP
Not in Commercial Distribution

  • 10884521214002 ()


  • CT system application software
PDU COMPONENT ASSEMBLE
GE Hualun Medical Systems Co., Ltd
XRa
In Commercial Distribution

  • 00840682120777 ()


  • Stationary basic diagnostic x-ray system, analogue
No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution

  • 00840682146586 ()


  • CT system application software
No Description
GE MEDICAL SYSTEMS, INC.
2
In Commercial Distribution

  • 00840682142601 ()


  • CT system application software
No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution

  • 00840682134989 ()


  • CT system application software
No Description
GE HEALTHCARE JAPAN CORPORATION
1.0
In Commercial Distribution

  • 00840682134972 ()


  • CT system application software
No Description
Advanced Bionics, LLC
AB-6500
In Commercial Distribution



  • Hearing implant implantable-component tester, postoperative
No Description
Advanced Bionics, LLC
CI-6101
In Commercial Distribution



  • Hearing implant implantable-component tester, postoperative
No Description
ELUCID BIOIMAGING INC.
A.2
In Commercial Distribution

  • B745VASCUCAPA2 ()


  • CT system application software
No Description
ELUCID BIOIMAGING INC.
A.3
In Commercial Distribution

  • B745ELUCIDVIVOA3 ()


  • CT system application software
No Description
ELUCID BIOIMAGING INC.
A.1.2
In Commercial Distribution

  • B745A40 ()


  • CT system application software
No Description
QUALITY ELECTRODYNAMICS LLC
2001001
In Commercial Distribution

  • 00814848020232 ()
MAC000112

  • Radiation therapy simulation system
No Description
QUALITY ELECTRODYNAMICS LLC
2001000
In Commercial Distribution

  • 00814848020218 ()
MAC000111

  • Radiation therapy simulation system
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
MB-715NT
In Commercial Distribution

  • B216MB715NT1 ()


  • Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 10-18mA, 50-90 kV
ARQUILLA, INC.
HF 718BD
In Commercial Distribution

  • B216HF718BD1 ()


  • Stationary basic diagnostic x-ray system, analogue
TABLE TOP X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
HDRI-715A-40
In Commercial Distribution

  • B216HDRI715A401 ()


  • Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 10mA, 50-90kV
ARQUILLA, INC.
FB910A-40K
In Commercial Distribution

  • B216FB910A40K1 ()


  • Stationary basic diagnostic x-ray system, analogue
TABLE TOP X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
DRH-700 A/C
In Commercial Distribution

  • B216DRH700AC1 ()


  • Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
BDXC-700
In Commercial Distribution

  • B216BDXC7001 ()


  • Stationary basic diagnostic x-ray system, analogue
No Description
Advanced Bionics, LLC
CI-6101
Not in Commercial Distribution

  • 07630016841552 ()


  • Hearing implant implantable-component tester, postoperative
No Description
Advanced Bionics, LLC
CI-6101
Not in Commercial Distribution

  • 07630016817137 ()


  • Hearing implant implantable-component tester, postoperative
No Description
Advanced Bionics, LLC
AB-6500
Not in Commercial Distribution

  • 07630016809705 ()


  • Hearing implant implantable-component tester, postoperative
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
P700M A/C
In Commercial Distribution

  • B216P700MAC1 ()


  • Stationary basic diagnostic x-ray system, analogue
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
LB-715NT
In Commercial Distribution

  • B216LB715NT1 ()


  • Stationary basic diagnostic x-ray system, analogue
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