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Digital Portable X-ray Units, Model SP-HF-4.0 D

by Sedecal USA, Inc.

510(k) K042361

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 · Special NumberK042361 Date29 Sep 2004ClearedStatusActive

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  • Withdrawn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, 26 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 Digital Portable X-ray Units, Model SP-HF-4.0 D is a portable X-ray system that operates from 120 V 50-60 Hz AC power. It utilizes a high frequency inverter mounted to a tripod or support arm for diagnostic imaging purposes.

This device is supplied as a Class II X-ray system and is authorized under FDA 510(k) clearance with K number K042361. The device is intended for use in radiology settings and is manufactured by Sedecal USA, Inc.

Other devices from Sedecal USA, Inc.

Questions

AI-generated answers, 26 Sep 2026

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

  • What is the Digital Portable X-ray Units, Model SP-HF-4.0 D used for?

    This device is a portable X-ray system designed for diagnostic imaging purposes, utilizing a high frequency inverter mounted to a tripod or support arm to enable mobile radiographic imaging in clinical settings.

  • How is the Digital Portable X-ray Units, Model SP-HF-4.0 D powered and supplied?

    The device operates from 120 V 50-60 Hz AC power and is supplied as a complete Class II X-ray system, including the high frequency inverter and mounting components for tripod or support arm use.

  • What regulatory authorization does the Digital Portable X-ray Units, Model SP-HF-4.0 D have?

    The device is authorized under FDA 510(k) clearance with K number K042361, indicating it was found substantially equivalent to a legally marketed predicate device.