| Device Type ID | 4424 |
| Device Name | Device, Communications, Images, Ophthalmic |
| Regulation Description | Medical Image Communications 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 | 892.2020 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NFG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4424 |
| Device | Device, Communications, Images, Ophthalmic |
| Product Code | NFG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Medical Image Communications Device. |
| CFR Regulation Number | 892.2020 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Alcon Research, Ltd. | II | Apr-14-2016 |