Topcon Corporation · Class II · Cleared Jul 17, 2024
| K-number | K241081 |
| Device name | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System |
| Applicant | Topcon Corporation |
| Product code | OBO |
| Device class | Class II |
| Decision date | Jul 17, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 886.1570 |
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