# K211383: NFLK-2501 Portable X-ray Unit

- Pathway: 510(k) (Traditional)
- Applicant: Neuf, Inc.
- Decided: Aug 13, 2021 after 101 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: 1 generation back to K040046 (2004). 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)
- K040046: Minxray, Model HF120/60H Powerplus, Minxray, Inc. (2004) Summary page 4.

## Indications for use
The NFLK-2501 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient’s anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). The device may be used for handheld diagnostic imaging of body extremities. The system is subject to the following limitations of use when stand-mounted: - The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities. - The device may be used for imaging of the chest when used without a grid. This device is not intended for mammography.

Source page: https://510kreport.com/device/K211383
Methodology: https://510kreport.com/methodology