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Konica QX-70 Automatic X-Ray Film Processor

by Konica Medical Corp. 510(k)

Active United States

510(k) K931314

Overview

The Konica QX-70 Automatic X-Ray Film Processor is a Class II medical device classified as an Automatic Radiographic-Film Processor, designed for developing and processing radiographic film used in radiology. It automates the chemical processing of X-ray film to produce diagnostic images, ensuring consistent development and fixation for clinical evaluation. The device adheres to regulatory standards for radiographic film processing, supporting high-volume workflows in radiology departments.

This processor is intended for use in radiology settings, where it processes single-use radiographic film cassettes to produce developed images. Supplied as a reusable medical device, it requires proper maintenance and calibration to maintain performance. The system is not MRI-compatible and must be stored in a controlled environment to protect film sensitivity and processing chemistry. Authorized for commercial distribution in the U.S. under FDA 510(k) clearance (K931314), it operates under regulatory classification IXW and device code 892.1900.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK931314 Date7 Sep 1993ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 5 Oct 2026.

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

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Questions

  • What is the Konica QX-70 Automatic X-Ray Film Processor used for?

    The Konica QX-70 is designed to automate the chemical processing of radiographic film in radiology settings. It develops and fixes X-ray film cassettes to produce clear, diagnostic images for clinical evaluation, streamlining workflows in high-volume departments.

  • Is the Konica QX-70 a single-use or reusable device?

    The Konica QX-70 is a reusable medical device. It requires regular maintenance, calibration, and proper upkeep to ensure consistent performance and image quality over time.

  • What type of film does the QX-70 process, and how is it supplied?

    The QX-70 processes single-use radiographic film cassettes. The processor itself is supplied as a standalone unit, requiring compatible film and processing chemicals for operation.

  • Does the Konica QX-70 require any special storage conditions?

    Yes, the processor must be stored in a controlled environment to protect the film’s sensitivity and maintain the integrity of the processing chemistry. Avoid exposure to extreme temperatures, humidity, or direct light.

  • Is the Konica QX-70 compatible with MRI environments?

    No, the Konica QX-70 is not MRI-compatible. It should only be used in non-MRI settings to prevent interference or safety risks.