Harmony
FDA 510(k) clearance K182376 · decided 2018-09-28
Clearance details
- K-number
- K182376
- Device name
- Harmony
- Applicant
- Topcon Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-08-31
- Decision date
- 2018-09-28
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- NFJ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Oakland, NJ, US
- Third-party review
- No
- Expedited review
- No
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| ZEISS CLINIC 360 (K260694) | Carl Zeiss Meditec, AG | 2026-07-17 |
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| CALLISTO eye (K232944) | Carl Zeiss Meditec, AG | 2023-12-21 |
| Harmony (K232555) | Topcon Healthcare Solutions | 2023-11-20 |
| CALLISTO eye (K231676) | Carl Zeiss Meditec, AG | 2023-08-28 |
| Altris IMS (K232088) | Altris, Inc. | 2023-07-31 |
| Excelsior (K220929) | Merit Cro, Inc. | 2022-10-31 |
| FORUM (K213527) | Carl Zeiss Meditec, AG | 2022-08-15 |
| RetinAI Discovery (K211715) | Retinai Medical AG | 2022-04-28 |
| Harmony Referral System (K210396) | Topcon Healthcare Solutions EMEA Oy | 2021-09-13 |
Recalls involving this device
No recalls on record reference this clearance.