Endoscope, Accessories, Image Post-Processing For Color Enhancement
The Endoscope Image Post-Processing Accessory for Color Enhancement is a gastrointestinal device that provides an alternative mode of visualization using image post-processing algorithms applied to received white-light endoscopy images for color enhancement, improving mucosal visibility without using additional light sources. It falls under the Gastroenterology and Urology medical specialty and is classified as a Class 2 device under regulation 876.1500, requiring 510(k) premarket notification. This technology helps endoscopists identify subtle mucosal lesions or vascular patterns that may be less visible under standard white-light imaging. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PEA
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251127 | PENTAX Medical Video Processor (EPK-i8020c) | Jun 03, 2025 | Substantially Equivalent | Pentax of America, Inc. |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL | Jul 28, 2023 | Substantially Equivalent | Pentax of America, Inc. |
| K190805 | PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL | Dec 20, 2019 | Substantially Equivalent | Pentax of America, Inc. |
| K191282 | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family | Nov 08, 2019 | Substantially Equivalent | Pentax of America, Inc. |
| K173679 | PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes | Jul 03, 2018 | Substantially Equivalent | Pentax of America, Inc. |
| K160275 | Fuse Endoscopic System with FuseBox Processor | Aug 01, 2016 | Substantially Equivalent | Endochoice, Inc. |
| K150618 | PENTAX Medical EPK-i7010 Video Processor with GI Family | Nov 24, 2015 | Substantially Equivalent | Pentax of America, Inc. |
| K140149 | EPX-4440HD DIGITAL VIDEO PROCESSOR | Aug 22, 2014 | Substantially Equivalent | Fujifilm Medical Systems U.S.A, Inc. |
| K122470 | PENTAX EPK-I5010 VIDEO PROCESSOR | Apr 10, 2013 | Substantially Equivalent | Pentax Medical |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.