# K230581: TOPA12 Portable X-ray Unit

- Pathway: 510(k) (Traditional)
- Applicant: Neuf, Inc.
- Decided: Aug 16, 2023 after 167 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: 4 generations back to K040046 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222896: AirRay, Poskom Co., Ltd. (2022) Summary page 4.

## Indications for use
The TOPA 12 Portable X-Ray Unit is intended for use by a qualified/trained doctor or technician on adult subjects for taking diagnostic radiographic exposures for acquiring X-ray images of the desired parts of patient anatomy of extremities.

Source page: https://510kreport.com/device/K230581
Methodology: https://510kreport.com/methodology