| Device |
endoscope, accessories, image post-processing for color enhancement |
| Regulation Description |
Endoscope and accessories. |
| Definition |
Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement. |
| Physical State |
The system consists of flexible and/or rigid scope(s), light source(s), video processor and display. |
| Technical Method |
Image enhancement using image post-processing algorithms of the received white light image with the goal of enhancing visualization of suspicious images seen on white light. |
| Target Area |
Limited to endoscopic systems for observation of the gastro-urological tract. |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | PEA |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.1500
|
|---|
| 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
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
