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AX-300SE Automatic X-Ray Film Processor, 6586.027

by Alphatek Corp.

510(k) K924430

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK924430 Date27 Nov 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
IXW
Device Class
Class II
Regulation
21 CFR Part 892.1900
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 AX-300SE Automatic X-Ray Film Processor is a device used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. It is designed for use in radiology departments to process radiographic film efficiently.

This device is a Class II medical device manufactured by Alphatek Corp. It is supplied as a single unit and requires appropriate storage conditions. The device has received FDA 510(k) clearance with number K924430, issued on November 27, 1992, and is classified under product code IXW.

Other devices from Alphatek Corp.

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 AX-300SE Automatic X-Ray Film Processor used for?

    The AX-300SE is designed to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. It is specifically created for efficient processing of radiographic film in radiology departments.

  • How is the AX-300SE supplied and what are its storage requirements?

    The AX-300SE Automatic X-Ray Film Processor is supplied as a single unit. It requires appropriate storage conditions to maintain its functionality, though specific storage parameters are not detailed in the provided information.

  • What is the regulatory status of the AX-300SE Automatic X-Ray Film Processor?

    The AX-300SE is a Class II medical device that has received FDA 510(k) clearance with number K924430, issued on November 27, 1992. It is classified under product code IXW and was determined to be substantially equivalent.

  • Can the AX-300SE Automatic X-Ray Film Processor be reused or is it single-use?

    The device information does not specify whether the AX-300SE is designed for single-use or multiple reuse. As an automatic film processor, it appears to be intended for repeated processing of films rather than being disposable.