EPX-4440HD Digital Video Processor
FDA 510(k) K140149 · Fujifilm Medical Systems U.S.A, Inc.
510(k) numberK140149
Submission
- Device name
- EPX-4440HD Digital Video Processor
- Applicant
- Fujifilm Medical Systems U.S.A, Inc.
Wayne, NJ, US - Received
- January 22, 2014
- Decision date
- August 22, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEA – Endoscope, Accessories, Image Post-Processing For Color Enhancement
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
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| K251127 | PENTAX Medical Video Processor (EPK-i8020c)PEA · Traditional | Pentax of America, Inc. | 06/03/2025SE |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope…PEA · Traditional | Pentax of America, Inc. | 07/28/2023SE |
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| K173679 | PENTAX Medical EPK-i7010 Video Processor with EB Family of ScopesPEA · Traditional | Pentax of America, Inc. | 07/03/2018SE |
| K160275 | Fuse Endoscopic System with FuseBox ProcessorPEA · Traditional | Endochoice, Inc. | 08/01/2016SE |
| K150618 | PENTAX Medical EPK-i7010 Video Processor with GI FamilyPEA · Traditional | Pentax of America, Inc. | 11/24/2015SE |
| K122470 | Pentax EPK-I5010 Video ProcessorPEA · Traditional | Pentax Medical | 04/10/2013SE |
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Questions and answers
When was EPX-4440HD Digital Video Processor cleared by the FDA?
EPX-4440HD Digital Video Processor (K140149) received a 510(k) decision of Substantially Equivalent on August 22, 2014, 212 days after the submission was received.
What is the product code of K140149?
The FDA product code is PEA – Endoscope, Accessories, Image Post-Processing For Color Enhancement, a Class II (moderate risk) device regulated under 21 CFR 876.1500.