Harmony 5.03
by Topcon Healthcare Solutions, Inc.
Harmony 5.03 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 8 Dec 2020 (UDI-DI 00850003069012), 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 | Number00850003069012 | Date8 Dec 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK182376 | Date28 Sep 2018 | StatusActive |
Official records
- AccessGUDID record 00850003069012
- FDA 510(k) database K182376
Across registries
- FDA 510(k) K182376 decided 28 Sep 2018 Active
- FDA GUDID UDI-DI 00850003069012 listed 8 Dec 2020 Listed
Timeline
- Cleared FDA 510(k) K182376
- Listed FDA GUDID 00850003069012
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Harmony
- Generic name
- Camera application software
- Model / reference
- 5.03
- Primary DI / UDI-DI
- 00850003069012
- 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
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