# K133496: X Twin System

- Pathway: 510(k) (Traditional)
- Applicant: Roesys GmbH
- Decided: Dec 3, 2014 after 384 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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 K070528 (2007). 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)
- K070528: Philips Essenta DR, Philips Medical Systems GmbH, Dmc (2007) Summary page 5.

## Indications for use
The X Twin is intended to be used as a digital multifunctional x-ray system, suitable for all radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography. X Twin shall only be operated by qualified, trained professionals. The patient can be in sitting, lying or standing position. The device is a permanently installed device and is intended to be operated in medical rooms with appropriate radiation protection only. It is not intended to be used with flammable anesthetic agents or in potentially explosive atmospheres.

Source page: https://510kreport.com/device/K133496
Methodology: https://510kreport.com/methodology