Harmony 5.06
by Topcon Healthcare Solutions, Inc.
Harmony 5.06 is a Class II device made by Topcon Healthcare Solutions, Inc., cleared under FDA 510(k) K182376 on 28 Sep 2018 and listed in FDA GUDID since 29 Jan 2021 (UDI-DI 00850003069128), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850003069128 | Date29 Jan 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182376 | Date28 Sep 2018 | StatusActive |
Official records
- AccessGUDID record 00850003069128
- FDA 510(k) database K182376
Across registries
- FDA 510(k) K182376 decided 28 Sep 2018 Active
- FDA GUDID UDI-DI 00850003069128 listed 29 Jan 2021 Listed
Timeline
- Cleared FDA 510(k) K182376
- Listed FDA GUDID 00850003069128
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Harmony
- Generic name
- Camera application software
- Model / reference
- 5.06
- Primary DI / UDI-DI
- 00850003069128
- 510(k) Number
- FDA product code
- NFJ
- GMDN term
- Camera application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code NFJ (System, Image Management, Ophthalmic).
- OVision Imaging System by OPHTHALMIC LABS, INC.
- CellChek 20 rc by KONAN MEDICAL, INC.
- IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR by Topcon Corp.
- CARA by Diagnos, Inc.
- Harmony Referral System 3.12.0 by Topcon Healthcare Solutions EMEA Oy
- Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System by Welch Allyn, Inc.
- CALLISTO eye 3.7 by Carl Zeiss Meditec AG
- Altris IMS System by Altris, Inc.
- Forum Archive & Viewer Forum Assist Match by Carl Zeiss Meditec AG
- KOWA VK-2s by Kowa Co. Ltd. Chofu