| Device |
diabetic retinopathy detection device |
| Regulation Description |
Retinal diagnostic software device. |
| 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. |
| 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 |
|---|
| Product Code | PIB |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
886.1100
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
