# K222625: Shield System

- Pathway: 510(k) (Special)
- Applicant: Radiaction, Ltd.
- Decided: Sep 30, 2022 after 30 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K260607: Shield System (Siemens 30x40) (2026), 0 descendants of its own

## 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 or Siemens Artis 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/K222625
Methodology: https://510kreport.com/methodology