# K200216: 4K UHD Camera System

- Pathway: 510(k) (Traditional)
- Applicant: Scivita Medical Technology Co., Ltd.
- Decided: Aug 21, 2020 after 206 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- 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.
No later device cites it as a predicate yet.
3 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151011: Visera 4K Uhd System, Olympus Medical Systems Corp. (2015) Summary page 5.

## Indications for use
4K UHD Camera System is used to provide imaging of the operative area in endoscopic surgery. 4K Camera Control Unit The 4K camera control unit has been designed to be used with endoscopes, 4K camera head, light source, monitors, and other ancillary equipment for endoscopic diagnosis, treatment, and observation. The 4K camera head is compatible with the 4K camera control unit only. 4K Camera Head The 4K camera head has been designed to be used with endoscopes, 4K camera control unit, and other ancillary equipment for endoscopic diagnosis, treatment, and observation.

Source page: https://510kreport.com/device/K200216
Methodology: https://510kreport.com/methodology