PEA
- Product code
- PEA
- Device name
- Endoscope, Accessories, Image Post-Processing For Color Enhancement
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 9 (all years; only the last 3 years are listed here)
FDA classification definition
Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251127 | 2025-06-03 | Pentax of America, Inc. | PENTAX Medical Video Processor (EPK-i8020c) |
Official FDA classification page: PEA
Classification and pathway per current FDA publications. Data from openFDA (CC0).