# K212159: Shield System

- Pathway: 510(k) (Traditional)
- Applicant: Radiaction, Ltd.
- Decided: Mar 30, 2022 after 261 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Radiaction’s Shield System is intended for reducing unnecessary exposure to scatter X-ray radiation of medical teams during fluoroscopy-guided procedures with the Toshiba Infinix-I C-arm, by attenuating scatter radiation. It is not intended to be used with such procedures for head and neck areas.

Source page: https://510kreport.com/device/K212159
Methodology: https://510kreport.com/methodology