Identity
- Trade Name
- Harmony FDA UDI
- Generic Name
- Camera application software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 5.05.100 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850003069197 FDA UDI
- 510(k) Number
- K182376 FDA UDI
- FDA Product Code
- NFJ FDA UDI
- GMDN Term
- Camera application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Camera application software
Harmony by Topcon Healthcare Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Synergy ODM — Topcon Healthcare, Inc. · Class II
- Harmony — Topcon Healthcare, Inc. · Class II
- Harmony — Topcon Healthcare, Inc. · Class II
- TigerView — Televere Systems · Class II
- Harmony — Topcon Healthcare, Inc. · Class II
Cleared under the same submission
K182376 also covers:
- Harmony — TOPCON HEALTHCARE SOLUTIONS, INC.
- Harmony — TOPCON HEALTHCARE SOLUTIONS, INC.
- Harmony — TOPCON HEALTHCARE SOLUTIONS, INC.
- Harmony — TOPCON HEALTHCARE SOLUTIONS, INC.
- Harmony — TOPCON HEALTHCARE SOLUTIONS, INC.
- Harmony — TOPCON HEALTHCARE SOLUTIONS, INC.
- Harmony — TOPCON HEALTHCARE SOLUTIONS, INC.
- Harmony — TOPCON HEALTHCARE SOLUTIONS, INC.
- Harmony — TOPCON HEALTHCARE SOLUTIONS, INC.
- Harmony — TOPCON HEALTHCARE SOLUTIONS, INC.
- Harmony — TOPCON HEALTHCARE SOLUTIONS, INC.
- Harmony — Topcon Healthcare, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Topcon Healthcare Solutions, Inc.
Sources (1)
- FDA UDI 4d62bb41-b5fa-4282-8e37-cb4f17aed831 34 fields · synced Jun 6, 2026