Definition: PJZ Cameras Are Prescription Devices Indicated Only For The Capture And Storage Of Images Of The Eye And Surrounding Area In The General Population. PJZ Cameras Cannot Be Indicated For Any Specific Population (e.g., Pediatrics, AMD Patients, Etc.), C
| Device Type ID | 4405 |
| Device Name | Camera, Ophthalmic, General-use |
| Physical State | PJZ Cameras Are Designed For True Color Or Monochrome Imaging In Visible Spectrum Of Light And Consists Of An Incoherent Light Source, Image Forming Lens, Aperture, And A Sensitive Photodetector Array (e.g., A CCD Array) In The Image Plane. PJZ Exclu |
| Technical Method | PJZ Cameras Meet Optical Performance Characteristics Stated In The ISO 10940-2009 Standard, Ophthalmic Instruments— Fundus Cameras. PJZ Cameras Are Limited To Basic Processing Of The Displayed Image (brightness, Contrast, White Balance) And Does Not |
| Target Area | The Target Area Is The Eye (lid, Orbit) And Ocular Tissues (anterior And Posterior Segment). |
| Regulation Description | Ophthalmic Camera. |
| Regulation Medical Specialty | Ophthalmic |
| 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 | 886.1120 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PJZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4405 |
| Device | Camera, Ophthalmic, General-use |
| Product Code | PJZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ophthalmic Camera. |
| CFR Regulation Number | 886.1120 [🔎] |