# K163675: Processor VP-7000, Light Source BL-7000

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Apr 25, 2017 after 119 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- 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.
12 later devices descend from it; 5 cite it directly.
3 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140149: Epx-4440HD Digital Video Processor, Fujifilm Medical Systems U.S.A, Inc. (2014) Summary page 4.
- K122831: Video System Center, Olympus Medical Systems Corp. (2012) Summary page 4.

## Most influential descendants
- K192918: Video Laparoscope, Video Processor, Light Source (2020), 6 descendants of its own
- K203717: Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 (2021), 3 descendants of its own
- K250268: HyperSnap Surgical System (HSS) (2025), 1 descendant of its own
- K243260: FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R (2025), 1 descendant of its own
- K202130: FUJIFILM Video Laparoscope (2020), 1 descendant of its own

## Indications for use
Processor VP-7000 The VP-7000 unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and light source together with monitor, recorder and various peripheral devices. BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy. BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis. Light Source BL-7000 The BL-7000 Light Source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination. This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and video processor together with monitor, recorder and various peripheral devices.

Source page: https://510kreport.com/device/K163675
Methodology: https://510kreport.com/methodology