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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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Rhythm Express - 00860000272407

The Rhythm Express RX-1 mini will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 mini will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 mini incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 mini device uses an embedded cellular modem on the cellular network. The RX-1 mini device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.
VIVAQUANT, INC.
RX-1 mini
In Commercial Distribution

  • 00860000272407 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Holter Software - 00884838094895

Philips Holter Software w/ Zymed Alg
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution

  • 00884838094895 ()
860292

  • Electrocardiographic long-term ambulatory recording analyser application software

Neuro Cochlear Implant System - 03663227004014

Programming Device, Left Wired
NEURELEC
159689
In Commercial Distribution

  • 03663227004014 ()


  • Hearing aid/implant system programming interface unit

Neuro Cochlear Implant System - 03663227004007

Programming Device, Right Wired
NEURELEC
173414
In Commercial Distribution

  • 03663227004007 ()


  • Hearing aid/implant system programming interface unit

Neuro Cochlear Implant System - 03663227001976

CI-LINK OPERATING ROOM KIT (ZTI)
NEURELEC
178380
In Commercial Distribution

  • 03663227001976 ()


  • Hearing aid/implant system programming interface unit

Neuro Cochlear Implant System - 03663227001969

CI-LINK FITTING ROOM KIT
NEURELEC
178379
In Commercial Distribution

  • 03663227001969 ()


  • Hearing aid/implant system programming interface unit

Neuro Cochlear Implant System - 03663227001952

CI-Link exchange
NEURELEC
178378
In Commercial Distribution

  • 03663227001952 ()


  • Hearing aid/implant system programming interface unit

Neuro Cochlear Implant System - 03663227001532

Genie Medical CI Fitting Software
NEURELEC
178371
In Commercial Distribution

  • 03663227001532 ()


  • Hearing aid/implant system programming interface unit

Neuro Cochlear Implant System - 03663227000894

CI-Link Unit Programming System
NEURELEC
177545
In Commercial Distribution

  • 03663227000894 ()


  • Hearing aid/implant system programming interface unit

ANAEYES OCT for system linkage - 03615020000496

No Description
ESSILOR INTERNATIONAL
ANAEYES OCT
In Commercial Distribution

  • 03615020000496 ()


  • Camera application software

Earlens Wireless Updater - 08500130070000

Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
EWU01
Not in Commercial Distribution

  • 08500130070000 ()
EWU01

  • Hearing aid/implant system programming interface unit

Earlens Wireless Programmer - 00850013007110

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

Harmony - 00850003069296

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 - 00850003069265

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

IMAGEnet 6 - 00850003069241

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 - 00850003069234

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 - 00850003069227

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

Harmony - 00850003069197

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 - 00850003069173

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

IMAGEnet 6 - 00850003069142

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

Glaucoma Module - 00850003069135

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 - 00850003069128

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 - 00850003069111

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 - 00850003069098

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 - 00850003069081

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

IMAGEnet 6 - 00850003069074

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

IMAGEnet 6 - 00850003069050

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 - 00850003069043

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 - 00850003069036

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

Harmony - 00850003069593

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 - 00850003069586

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 - 00850003069579

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 - 00850003069562

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 - 00850003069555

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 - 00850003069548

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 - 00850003069531

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 - 00850003069524

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 - 00850003069517

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 - 00850003069500

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 - 00850003069432

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 - 00850003069357

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

IMAGEnet 6 - 00850003069302

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 - 00850003069289

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

IMAGEnet 6 - 00850003069203

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 - 00850003069180

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

IMAGEnet 6 - 00850003069166

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

IMAGEnet 6 - 00850003069029

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 - 00850003069012

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

IMAGEnet 6 - 00850003069005

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

Avatar Generation - 04250668606670

N/A
Carl Zeiss Vision GmbH
000000-2351-295
Not in Commercial Distribution

  • 04250668606670 ()
000000-2351-295

  • Camera application software
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