# K222584: Evis X1 Video System Center Olympus CV-1500, Colonovideoscope Olympus CF-HQ1100DL/I, Gastrointestinal Videoscope Olympus Gif-1100

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Apr 26, 2023 after 243 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931154 (1993). 31 ancestors in all.
2 later devices descend from it; 2 cite it directly.
3 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131780: Evis Exera Iii Video System, Olympus Medical Systems Corp. (2013) Summary page 6.

## Most influential descendants
- K243261: FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L (2025), 0 descendants of its own
- K250432: Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) (2025), 0 descendants of its own

## Recalls of this device
- Aug 21, 2024 · Class II · Z-0181-2025: It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.

## Indications for use
The EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 is intended to be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product is designed to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, provide illumination to the endoscope, supply air through the endoscope while inside the body and control/monitor ancillary equipment. NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis. The CV-1500 Video System Center is compatible with scopes within the EVIS 190 and 1100 families. The COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I is intended to be used with an Olympus video system center, endoscope position detecting unit, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The COLONOVIDEOSCOPE CF-HQ1100DL &CF-HQ1100DI (product codes may be combined into a shorter code: CF-HQ1100DL/I) is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). The GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 is intended to be used with an Olympus video system center, Light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The GASTROINTESTINAL VIDEOSCOPE GIF-1100 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

Source page: https://510kreport.com/device/K222584
Methodology: https://510kreport.com/methodology