# K173921: HD-500 Video Endoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Sonoscape Medical Corp.
- Decided: Sep 5, 2018 after 253 days
- Product code: NWB (Endoscope, Accessories, Narrow Band Spectrum)
- 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: 8 generations back to K931154 (1993). 28 ancestors in all.
2 later devices descend from it; 1 cites it directly.
3 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100584: Evis Exeraii 180 System, Olympus Medical Systems Corporation (2010) Summary page 6.

## Most influential descendants
- K211882: HD-550 Video Endoscope System (2022), 1 descendant of its own
- K222020: HD-550 Video Endoscope System (2022), 0 descendants of its own

## Indications for use
HD-500 Video Endoscope System The HD-500 Video Endoscope System, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopies examination, diagnosis and treatment of the disease of the upper and lower gastrointestinal tract. HDL-500 Series Light Source, HDL-500E, HDL-500X The HDL-500 Series Light Source has been designed to be used with the endoscope, image processor and other peripheral devices for endoscopic observation, diagnosis and treatment. HD-500 Series Image Processor, HD-500, HD-500S, HD-330Plus The HD-500 Series Image Processor has been designed to be used with the endoscope, light source, monitor and other peripheral devices for endoscopic observation, diagnosis, treatment, and video recording. EG-500 Series Video Gastroscope, EG-500, EG-500L The EG-500 Series Video Gastroscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the upper digestive tract (including the esophagus, stomach and duodenum). EC-500 Series Video Colonoscope, EC-500, EC-500T, EC-500L, EC-500L/T The EC-500 Series Video Colonoscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the lower digestive tract (including the anus, rectum, colon and ileocecal segment).

Source page: https://510kreport.com/device/K173921
Methodology: https://510kreport.com/methodology