# K970598: Integrated Visualization System

- Pathway: 510(k) (Traditional)
- Applicant: Urohealth, Inc.
- Decided: Mar 12, 1997 after 22 days
- Product code: FCW (Light Source, Fiberoptic, Routine)
- 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: 1 generation back to K951647 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951647: Welch Allyn HI - Lux Illuminator, Welch Allyn, Inc. (1995) Summary page 1.
- K963046: Endocam, Corin USA (1996) Summary page 1.
- (no number) Integrated Video System: named in the summary without a submission number

## Indications for use
The IVS is used in providing illumination for endoscopic procedures and transmitting an image from an endoscope to a viewing monitor, which is integral to the system.

Source page: https://510kreport.com/device/K970598
Methodology: https://510kreport.com/methodology