| Device Type ID | 1663 |
| Device Name | System, Imaging, Fluorescence |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MRK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1663 |
| Device | System, Imaging, Fluorescence |
| Product Code | MRK |
| FDA Device Classification | Class 3 Medical Device |