| Device Type ID | 4426 |
| Device Name | Device, Hardcopy, Images, Ophthalmic |
| Regulation Description | Medical Image Hardcopy Device. |
| Regulation Medical Specialty | Radiology |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 892.2040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NFI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 4426 |
| Device | Device, Hardcopy, Images, Ophthalmic |
| Product Code | NFI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Medical Image Hardcopy Device. |
| CFR Regulation Number | 892.2040 [🔎] |