# K183675: 3D Visualization System

- Pathway: 510(k) (Traditional)
- Applicant: Scivita Medical Technology Co., Ltd.
- Decided: Sep 25, 2019 after 271 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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). 37 ancestors in all.
No later device cites it as a predicate yet.
3 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123365: Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190, Olympus Medical Systems Corp. (2013) Summary page 4.

## Indications for use
This 3D Visualization System is intended to compose the imaging signals from video system center and convert them into 3D signals displayed on the monitor.

Source page: https://510kreport.com/device/K183675
Methodology: https://510kreport.com/methodology