Definition: A Retinal Diagnostic Software Device Is A Prescription Software Device That Incorporates An Adaptive Algorithm To Evaluate Ophthalmic Images For Diagnostic Screening To Identify Retinal Diseases Or Conditions.
| Device Type ID | 4403 |
| Device Name | Diabetic Retinopathy Detection Device |
| Physical State | Installed On, And Operated By, An Off-the-shelf Hardware System With An Appropriate OS. |
| Technical Method | Software As A Medical Device Designed To Analyze Digital Fundus Images Taken With An Ophthalmic Camera. Using Artificial Intelligence Algorithms, The Device Is Able To Determine Whether A Patient Has Referable Retinopathy. |
| Target Area | Fundus Images Of The Macula And Optic Nerve Of The Eye. |
| 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) |
| CFR Regulation Number | 886.1100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PIB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4403 |
| Device | Diabetic Retinopathy Detection Device |
| Product Code | PIB |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 886.1100 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
IDX, LLC | ||
GRANTED | 1 | |