# K101810: 3DHJD Camera System Model

- Pathway: 510(k) (Abbreviated)
- Applicant: Vision Systems Group, A Division of Viking Systems
- Decided: Aug 30, 2010 after 62 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: 6 generations back to K923160 (1992). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021290: Vista Visualization System, Model 9000, Vista Visualization System with Voice Activation and Pip, Model 9100, Vista Medical Technologies, Inc. (2002) Summary page 1.
- K081585: Endoscopy Video Camera System, Vision Systems Group, A Division of Viking Systems (2008) Summary page 1.

## Indications for use
For use in all types of video assisted minimally invasive procedures including: general surgery, gynecologic, thoracic, urologic, bariatric, spinal, ENT and as an aid in visualization of cardiac structures.

Source page: https://510kreport.com/device/K101810
Methodology: https://510kreport.com/methodology