# K150618: PENTAX Medical EPK-i7010 Video Processor with GI Family

- Pathway: 510(k) (Traditional)
- Applicant: Pentax of America, Inc.
- Decided: Nov 24, 2015 after 259 days
- Product code: PEA (Endoscope, Accessories, Image Post-Processing For Color Enhancement)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931154 (1993). 34 ancestors in all.
3 later devices descend from it; 2 cite it directly.
3 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122470: Pentax Epk-I5010 Video Processor, Pentax Medical (2013) Summary page 4.

## Most influential descendants
- K231249: PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL (2023), 1 descendant of its own
- K251127: PENTAX Medical Video Processor (EPK-i8020c) (2025), 0 descendants of its own
- K191282: PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family (2019), 0 descendants of its own

## Indications for use
The PENTAX Medical EPK-i7010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipment for gastrointestinal endoscopic diagnosis, treatment and video observation. The PENTAX Medical EPK-i7010 includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™) and an optical imaging enhancement technology (OE).These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX video gastrointestinal endoscopes.

Source page: https://510kreport.com/device/K150618
Methodology: https://510kreport.com/methodology