# K260607: Shield System (Siemens 30x40)

- Pathway: 510(k) (Special)
- Applicant: Radiaction, Ltd.
- Decided: Jul 31, 2026 after 157 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
Longest line of descent: 1 generation back to K222625 (2022). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222625: Shield System, Radiaction, Ltd. (2022) Summary page 5.

## 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/K260607
Methodology: https://510kreport.com/methodology