# K222890: Radiance Ultra 32 4K Zerowire Duo

- Pathway: 510(k) (Special)
- Applicant: Nds Surgical Imaging, LLC
- Decided: Oct 19, 2022 after 26 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: 5 generations back to K081995 (2008). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161228: Radiance Ultra Series ZeroWire Embedded, Nds Surgical Imaging, LLC (2016) Summary page 4.
- K151609: ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2, Nds Surgical Imaging, LLC (2015) Summary page 4.

## Indications for use
The Radiance Ultra 32" 4K ZeroWire Duo is a paired wireless video communication transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy camera/processor, or other video source over a radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The Radiance Ultra 32" 4K ZeroWire Duo is a non-sterile reusable device not intended for use in the sterile field.

Source page: https://510kreport.com/device/K222890
Methodology: https://510kreport.com/methodology