Definition: An Ophthalmic Slit-scanning Camera Is An AC-powered Device Intended To Take Photographs Of The Eye And The Surrounding Area.
| Device Type ID | 4422 |
| Device Name | Camera, Ophthalmic, Slit-scanning |
| Physical State | Slit-scanning Cameras Consist Of An Incoherent Light Source, Image Forming Lens, Slit Forming Optics, Scanner, An Image Sensor, And Image Reconstruction Software. |
| Technical Method | The Imaging Plane Is Scanned By A Rectangular Slit Of Non-coherent Light And Reflected Images Of The Illuminated Areas Are Sequentially Captured By An Imaging Sensor. An Ophthalmic Image Is Reconstructed From Individual Slit Images In Software. |
| Target Area | Eye And Ocular Tissues (anterior And Posterior Segment). |
| Regulation Description | Ophthalmic Camera. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Submission Type | 510(k) |
| CFR Regulation Number | 886.1120 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QER |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4422 |
| Device | Camera, Ophthalmic, Slit-scanning |
| Product Code | QER |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ophthalmic Camera. |
| CFR Regulation Number | 886.1120 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CARL ZEISS MEDITEC INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARL ZEISS MEDITEC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |