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Buckymatic Automatic Chest Film Changer

by Acoma Medical Imaging, Inc.

510(k) K925598

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 NumberK925598 Date1 Feb 1993ClearedStatusActive

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  • Withdrawn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
KPX
Device Class
Class II
Regulation
21 CFR Part 892.1860
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Buckymatic Automatic Chest Film Changer is a Class II medical device designed for radiology departments. It is an automatic film changer used in chest radiography to facilitate the exchange of radiographic film cassettes during imaging procedures.

This device is manufactured by Acoma Medical Imaging, Inc. and is supplied as a reusable unit. It received FDA 510(k) clearance with K number K925598 on February 1, 1993, and is classified under product code KPX for radiology applications. The device is intended for use in radiology settings and is not specified as single-use or MRI compatible.

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Questions

AI-generated answers, 1 Oct 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 Buckymatic Automatic Chest Film Changer used for?

    The Buckymatic is an automatic film changer designed specifically for chest radiography in radiology departments. It facilitates the exchange of radiographic film cassettes during imaging procedures, streamlining the radiographic process.

  • Is the Buckymatic Automatic Chest Film Changer a single-use device?

    No, the Buckymatic Automatic Chest Film Changer is supplied as a reusable unit. It is designed for repeated use in radiology settings rather than being disposable after a single procedure.

  • What regulatory approvals does the Buckymatic Automatic Chest Film Changer have?

    The device received FDA 510(k) clearance with K number K925598 on February 1, 1993. It is classified as a Class II medical device under product code KPX for radiology applications.

  • What are the specifications of the Buckymatic Automatic Chest Film Changer?

    The Buckymatic is manufactured by Acoma Medical Imaging, Inc. and is intended for use in radiology settings. It is not specified as MRI compatible. The device is designed to facilitate the exchange of radiographic film cassettes during chest imaging procedures.