PEA — Endoscope, Accessories, Image Post-Processing For Color Enhancement Class II
Classification Details
- Product Code
- PEA
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251127 | pentax of america | PENTAX Medical Video Processor (EPK-i8020c) | June 3, 2025 |
| K231249 | pentax of america | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope E | July 28, 2023 |
| K190805 | pentax of america | PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope E | December 20, 2019 |
| K191282 | pentax of america | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family | November 8, 2019 |
| K173679 | pentax of america | PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes | July 3, 2018 |
| K160275 | endochoice | Fuse Endoscopic System with FuseBox Processor | August 1, 2016 |
| K150618 | pentax of america | PENTAX Medical EPK-i7010 Video Processor with GI Family | November 24, 2015 |
| K140149 | fujifilm medical systems u.s.a | EPX-4440HD DIGITAL VIDEO PROCESSOR | August 22, 2014 |
| K122470 | pentax medical | PENTAX EPK-I5010 VIDEO PROCESSOR | April 10, 2013 |