Definition: Alternative Mode Of Visualization Using Image Post-processing Algorithms Of The Received White Light Image For Color Enhancement.
| Device Type ID | 2087 |
| Device Name | Endoscope, Accessories, Image Post-processing 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 Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PEA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2087 |
| Device | Endoscope, Accessories, Image Post-processing For Color Enhancement |
| Product Code | PEA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ENDOCHOICE INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FUJIFILM CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOYA CORPORATION PENTAX DIVISION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Image Display Error / Artifact | 33 |
No Display / Image | 7 |
Monitor | 6 |
Poor Quality Image | 5 |
Leak / Splash | 2 |
Sparking | 2 |
Device Operates Differently Than Expected | 1 |
Endoscope | 1 |
Lenses | 1 |
Device Contamination With Biological Material | 1 |
Device Issue | 1 |
Moisture Damage | 1 |
Positioning Problem | 1 |
Fluid Leak | 1 |
Output Problem | 1 |
| Total Device Problems | 64 |