# K221781: Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Optomedic Technologies, Inc.
- Decided: Feb 2, 2023 after 226 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: 3 generations back to K944620 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131953: IMAGE1 Spies, KARL STORZ Endoscopy-America, Inc. (2013) Summary page 4.

## Indications for use
Image Processing Unit is intended to be used with compatible laparoscopes, camera heads, light sources, monitors, and other ancillary equipment for visualization, image recording and documentation during laparoscopic procedures. Endoscopic Camera Head is intended to be used with compatible laparoscopes, image processing unit, and other ancillary equipment for visualization, image recording and documentation during laparoscopic procedures.

Source page: https://510kreport.com/device/K221781
Methodology: https://510kreport.com/methodology