# K120278: Wireless Image Transmitter Unit

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Aug 10, 2012 after 193 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: 2 generations back to K081995 (2008). 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)
- K100195: NDS Surgical Imaging, LLC for the Zerowire Duo Wireless HD Video Transfer System, Model WU-WX-WY (Where U=R or T, W=P, X, Nds Surgical Imaging (2010) Summary page 2.

## Indications for use
The Olympus Wireless Image Transmitter Unit UWIT-YOOO1 is a paired transmitter and receiver, intended for delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures. The Olympus UWIT-YO001 is a non-sterile reusable device not intended for use in the sterile field. It is intended for use by qualified physicians having complete knowledge of these surgical procedures.

Source page: https://510kreport.com/device/K120278
Methodology: https://510kreport.com/methodology