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NFLK-2501 Portable X-ray Unit

by Neuf, Inc.

510(k) K211383

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK211383 Date13 Aug 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IZL
Device Class
Class II
Regulation
21 CFR Part 892.1720
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The NFLK-2501 Portable X-ray Unit is a mobile radiographic imaging system designed for generating X-ray images. Classified as a System, X-Ray, Mobile, it produces diagnostic-quality radiographs for medical and veterinary applications. The device features adjustable output parameters (40–100 kV, 20–35 mA, 0.4–120 mAs) with a maximum power of 2.5 kW.

This portable X-ray unit is intended for use in settings requiring mobility, such as emergency rooms, operating rooms, or veterinary clinics. Supplied as a reusable device, it holds FDA clearance under a 510(k) submission (K211383) and is regulated under 21 CFR 892.1720. The device is not MRI-safe or single-use.

NFLK-2501 Portable X-ray Unit

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