# K222258: Combined High Frequency X-ray Source

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Powersite Electric Co., Ltd.
- Decided: Nov 1, 2022 after 97 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K020436 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103522: Sedecal, Sedecal., Sa. (2011) Summary page 5.

## Indications for use
The Combined High Frequency X-ray Source is intended for use by a qualified/trained technician on both adult and pediatric subjects for body extremities and cervical spine exclusively. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)

Source page: https://510kreport.com/device/K222258
Methodology: https://510kreport.com/methodology