# K222896: AirRay

- Pathway: 510(k) (Traditional)
- Applicant: Poskom Co., Ltd.
- Decided: Dec 20, 2022 after 88 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: 3 generations back to K040046 (2004). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182207: TR90BH, Minxray, Inc. (2018) Summary page 6.

## Most influential descendants
- K230581: TOPA12 Portable X-ray Unit (2023), 0 descendants of its own

## Indications for use
The POSKOM Portable X-ray unit is a device that can conveniently generate X-rays for diagnosis when the patient condition is difficult to move. Mainly used by trained specialists, doctors or radiologists. Indication: The POSKOM Battery Type Portable X-ray Unit is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the body parts. The device must be used for stand mounted diagnostic imaging of head, abdomen, or extremities. The device must be used for stand mounted imaging of the chest. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Contraindication: The use of X-radiation for diagnostic purposes in the following subjects is contraindicated. - Pregnancy, especially first trimester

Source page: https://510kreport.com/device/K222896
Methodology: https://510kreport.com/methodology