| Device |
home monitoring ophthalmic optical coherence tomography (oct) imaging device |
| Definition |
A home monitoring ophthalmic imaging device is a prescription self-imaging device that incorporates imaging system hardware and automated image processing and analysis to enable patients at home to provide measurements that are intended for use by a physician for monitoring ophthalmic diseases or conditions in between regularly scheduled assessments. |
| Physical State |
An AC-powered or battery-powered device containing OCT hardware (optics and electronics), software and firmware for capturing images. Analysis algorithms are included as part of software. |
| Technical Method |
The device allows the user to capture optical coherence tomography images of the eye. Using automated image analysis algorithms, the device provides additional analysis to segment and quantify regions or features of interest for the physician to interpret. |
| Target Area |
Eye |
| Regulation Medical Specialty |
Ophthalmic |
| Review Panel |
Ophthalmic |
|---|
| Product Code | SAX |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Ophthalmic Devices
(DHT1A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
886.1600
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
