Endoscope, Accessories, Image Post-Processing For Color Enhancement
FDA product code PEA · 7 cleared devices
Class 2
Gastroenterology, Urology
- Regulation
- 21 CFR 876.1500
- Review panel
- GU
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2013-04-10 – 2025-06-03
Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.
PEA
2025-06-03
PEA
2023-07-28
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL
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PEA
2019-12-20
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
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PEA
2019-11-08
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
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PEA
2018-07-03
PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
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PEA
2016-08-01
Fuse Endoscopic System with FuseBox Processor
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PEA
2013-04-10
PENTAX EPK-I5010 VIDEO PROCESSOR
View details →No matching devices.
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