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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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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
Harmony 5.06 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
In Commercial Distribution

  • 00850003069128 ()


  • Camera application software
Harmony 5.05 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
In Commercial Distribution

  • 00850003069111 ()


  • Camera application 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 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 5.07.004 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
Glaucoma Module 1.00 is a software application intended for the management, display and analysis of visual field and optical coherence tomography data.
TOPCON HEALTHCARE SOLUTIONS, INC.
1.00
In Commercial Distribution

  • 00850003069135 ()


  • Camera application software
Harmony 5.03.200 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.
5.03.200
In Commercial Distribution

  • 00850003069098 ()


  • Camera application software
Synergy ODM 4.09.500 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.
4.09.500
Not in Commercial Distribution

  • 00850003069081 ()


  • Camera application software
The IMAGEnet 6 ver. 2.1.0 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.
2.1.0
In Commercial Distribution

  • 00850003069074 ()


  • Camera application software
The IMAGEnet 6 ver. 2.0.3 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.
2.0.3
In Commercial Distribution

  • 00850003069050 ()


  • Camera application software
Harmony 5.04 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
Not in Commercial Distribution

  • 00850003069043 ()


  • Camera application software
Synergy ODM 4.10.500 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.
4.10.500
Not in Commercial Distribution

  • 00850003069036 ()


  • Camera application software
The IMAGEnet 6 ver. 2.0.2 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.
2.0.2
In Commercial Distribution

  • 00850003069029 ()


  • Camera application software
Harmony 5.03 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.
5.03
In Commercial Distribution

  • 00850003069012 ()


  • Camera application software
The IMAGEnet 6 ver. 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.
2.0
In Commercial Distribution

  • 00850003069005 ()


  • Camera application software
Software version is in Application Identifier (8012) Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
WPUSB01
Not in Commercial Distribution

  • 00850013007110 ()
WPUSB01

  • Hearing aid/implant system programming interface unit
MoMe® Software Platform is a web-based remote server software with proprietary algorithms for analysis of ECG data. It analyzes the data via the embedded algorithm and when indicated, data identified by the algorithm is flagged for physician review. The data is sent to the Software Platform from the MoMe® Kardia , a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring.
Infobionic, Inc.
1400
In Commercial Distribution

  • B690MS10 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSERV-6AA-XXXXA
In Commercial Distribution

  • 00812345029857 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AC-YXXXC
In Commercial Distribution

  • 00812345029840 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBEWS-6AC-YXXXX
In Commercial Distribution

  • 00812345029826 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSCRIBE-6AC-XXXXX
In Commercial Distribution

  • 00812345027334 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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