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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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No Description
GE Healthcare Austria GmbH & Co OG
18
In Commercial Distribution

  • 00840682137621 ()


  • Ultrasound imaging system operation software
No Description
GE Healthcare Austria GmbH & Co OG
17
In Commercial Distribution

  • 00840682122788 ()


  • Ultrasound imaging system operation software
No Description
Lunit Inc.
1.1
In Commercial Distribution

  • 08800076000162 ()


  • X-ray image interpretive software
No Description
Lunit Inc.
1.0
In Commercial Distribution

  • 08800076000148 ()


  • X-ray image interpretive software
No Description
Lunit Inc.
1.1
In Commercial Distribution

  • 08800076000056 ()


  • X-ray image interpretive software
Dental treatment remote monitoring
DENTAL MONITORING
003
In Commercial Distribution

  • 03760405340251 ()
2001-001

  • Patient self-taken medical image communication software
  • Clinical management support software
Dental treatment remote monitoring
DENTAL MONITORING
003
In Commercial Distribution

  • 03760405340244 ()
2001-001

  • Patient self-taken medical image communication software
  • Clinical management support software
Dental treatment remote monitoring
DENTAL MONITORING
003
In Commercial Distribution

  • 03760405340237 ()
2001-001

  • Patient self-taken medical image communication software
  • Clinical management support software
Dental treatment remote monitoring
DENTAL MONITORING
003
In Commercial Distribution

  • 03770021392114 ()
2001-001

  • Patient self-taken medical image communication software
  • Clinical management support software
No Description
Prowess, Inc.
v5.61
In Commercial Distribution

  • 00859032007088 ()


  • Radiation therapy software
MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT Web app 1.1
In Commercial Distribution

  • 05056190500887 ()
MapRT Web app

  • Radiation therapy software
MapRT is used to assist treatment planning whereby the patient surface and positioning devices captured at simulation can be modelled against the treatment devices, such that any potential collisions can be predicted.
VISION RT LIMITED
MapRT Web app
In Commercial Distribution

  • 05056190500771 ()
MapRT Web app

  • Radiation therapy software
No Description
OPTOS PUBLIC LIMITED COMPANY
S90570
In Commercial Distribution

  • 05057056905709 ()


  • Ophthalmology PACS software
Standard Imaging IMSure 3D software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy.
STANDARD IMAGING INC.
91355
In Commercial Distribution

  • 00850019946604 ()
91355

  • Radiation therapy software
Standard Imaging IMSure 3D (IM3D) QA software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy.
STANDARD IMAGING INC.
91365
In Commercial Distribution

  • 00850019946543 ()
91365

  • Radiation therapy software
Harmony 6.2 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
6.2
In Commercial Distribution

  • 00850003069593 ()


  • Camera application software
Harmony 6.1.1 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
6.1.1
In Commercial Distribution

  • 00850003069586 ()


  • Camera application software
Harmony 6.1 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
6.1
In Commercial Distribution

  • 00850003069579 ()


  • Camera application software
Harmony 5.09.004 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
5.09.004
In Commercial Distribution

  • 00850003069562 ()


  • Camera application software
Harmony 5.09.003 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
5.09.003
In Commercial Distribution

  • 00850003069555 ()


  • Camera application software
Harmony 5.09.002 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
5.09.002
In Commercial Distribution

  • 00850003069548 ()


  • Camera application software
Harmony 6.0 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
6.0
In Commercial Distribution

  • 00850003069531 ()


  • Camera application software
Harmony 5.09.001 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
5.09.001
In Commercial Distribution

  • 00850003069524 ()


  • Camera application software
Harmony 5.09 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
5.09
In Commercial Distribution

  • 00850003069517 ()


  • Camera application software
Harmony 5.08.001 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
5.08.001
In Commercial Distribution

  • 00850003069500 ()


  • Camera application software
Harmony 5.08 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
5.08
In Commercial Distribution

  • 00850003069432 ()


  • Camera application software
Harmony 5.07.004 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
5.07.004
In Commercial Distribution

  • 00850003069357 ()


  • Camera application software
The IMAGEnet 6 ver. 2.4.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.
TOPCON HEALTHCARE SOLUTIONS, INC.
2.4.0
In Commercial Distribution

  • 00850003069302 ()


  • Camera application software
Harmony 5.06.003 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
5.06.003
In Commercial Distribution

  • 00850003069296 ()


  • Camera application software
Harmony 5.06.002 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
5.06.002
In Commercial Distribution

  • 00850003069289 ()


  • Camera application software
Harmony 5.07 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
5.07
In Commercial Distribution

  • 00850003069265 ()


  • Camera application software
The IMAGEnet 6 ver. 2.3.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.
TOPCON HEALTHCARE SOLUTIONS, INC.
2.3.0
In Commercial Distribution

  • 00850003069241 ()


  • Camera application software
Harmony 5.05.102 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
5.05.102
In Commercial Distribution

  • 00850003069234 ()


  • Camera application software
Harmony 5.05.101 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
5.05.101
In Commercial Distribution

  • 00850003069227 ()


  • Camera application software
The IMAGEnet 6 ver. 2.2.1 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.
TOPCON HEALTHCARE SOLUTIONS, INC.
2.2.1
In Commercial Distribution

  • 00850003069203 ()


  • Camera application software
Harmony 5.05.100 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
5.05.100
In Commercial Distribution

  • 00850003069197 ()


  • Camera application software
Harmony 5.04.200 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
5.04.200
In Commercial Distribution

  • 00850003069180 ()


  • Camera application software
Harmony 5.04.100 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
5.04.100
In Commercial Distribution

  • 00850003069173 ()


  • Camera application software
The IMAGEnet 6 ver. 2.2.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.
TOPCON HEALTHCARE SOLUTIONS, INC.
2.2.0
In Commercial Distribution

  • 00850003069166 ()


  • Camera application software
The IMAGEnet 6 ver. 2.1.1 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.
TOPCON HEALTHCARE SOLUTIONS, INC.
2.1.1
In Commercial Distribution

  • 00850003069142 ()


  • Camera application software
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