Harmony
Topcon Healthcare Solutions
TOPCON HEALTHCARE SOLUTIONS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013986459 | 3013986459 | TOPCON HEALTHCARE SOLUTIONS, INC. | 1 | Y | 2020-04-25 | 111 Bauer Drive Oakland NJ US 07436 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 211415 | 1442875884 | K182376 | Harmony | NFJ | 2018-09-28 |
| 211415 | 1760725639 | K171370 | IMAGEnet 6 Ophthalmic Data System | NFJ | 2017-11-01 |
| 211415 | 1829271736 | K151952 | Synergy ODM | NFJ | 2015-10-01 |
| 211415 | 1328881090 | ||||
| 211415 | 1525585314 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NFJ | 3 | 2018-09-28 |
PMN#
Harmony Referral System
Topcon Healthcare Solutions EMEA Oy
Glaucoma Module
Topcon Healthcare Solutions, Inc.
GUDID#
Harmony Referral System - 3.11.0
2026-01-28
Harmony Referral System - 3.10.0
2025-08-07
Synergy ODM - 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.
2020-03-02
Synergy ODM - 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.
2020-03-04
Harmony Referral System - 3.9.1
2024-05-15
Harmony Referral System - Harmony is a web-based software solution that connects all examination instruments, eye care professionals, and the latest technologies to ensure the best possible patient care and customer experience.
2023-08-22
Harmony - 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.
2021-02-26
Glaucoma Module - Glaucoma Module 1.00 is a software application intended for the management, display and analysis of visual field and optical coherence tomography data.
2021-02-26
Harmony - 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.
2021-02-09
Harmony - 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.
2021-02-04
Harmony - 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.
2021-01-29
Harmony - 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.
2021-01-26
Harmony - 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.
2021-01-19
Harmony - 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.
2021-01-14
Harmony - 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.
2021-01-12
Harmony - 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.
2020-12-22
IMAGEnet 6 - 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.
2020-12-09
Harmony - 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.
2020-12-09
Harmony - 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.
2020-12-08
Harmony - 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.
2020-11-25
Harmony - 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.
2020-10-02
IMAGEnet 6 - 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.
2020-06-23
IMAGEnet 6 - 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.
2019-09-19
IMAGEnet 6 - 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.
2019-09-19
IMAGEnet 6 - 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.
2019-02-14
IMAGEnet 6 - 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.
2019-02-13
IMAGEnet 6 - 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.
2019-02-12
IMAGEnet 6 - 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.
2019-04-24
IMAGEnet 6 - 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.
2019-08-05