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Radiographic Film Processor, Models XP400 and XP1000

by Daito Co., Ltd. 510(k)

Active United States

510(k) K024342

Overview

The Radiographic Film Processor, Models XP400 and XP1000, is an automatic device classified as a Processor, Radiographic-Film. It automates the development of exposed x-ray films using a roller transport system to sequentially move film through developer, fixer, and wash solutions, ensuring consistent processing.

Used in clinical radiology settings, this device requires exposed sheet film as input and produces processed film as output. It features an infrared heater for drying, a light-proof cover, and an automatic standby mode. Supplied as a reusable Class II device under FDA 510(k) clearance (K024342), it adheres to regulation 892.1900 and is intended for use by radiology staff.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK024342 Date23 Apr 2003ClearedStatusActive

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 6 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

Questions

  • What clinical setting is the Radiographic Film Processor, Models XP400 and XP1000, designed for use in?

    The Radiographic Film Processor, Models XP400 and XP1000, is specifically designed for use in clinical radiology settings. It automates the development of exposed x-ray films, making it ideal for environments where consistent and efficient film processing is required, such as hospitals, diagnostic imaging centers, or radiology departments.

  • How is the Radiographic Film Processor, Models XP400 and XP1000, supplied and what type of device is it?

    The Radiographic Film Processor, Models XP400 and XP1000, is supplied as a reusable Class II medical device. It is not single-use, meaning it is intended to be used repeatedly after proper maintenance and cleaning, as outlined in the manufacturer’s guidelines.

  • What key features does the Radiographic Film Processor, Models XP400 and XP1000, include to ensure proper film processing?

    The processor includes an infrared heater for drying the film, a light-proof cover to prevent exposure to light during processing, and an automatic standby mode to conserve energy when not in use. These features help ensure consistent and reliable film development.

  • What regulatory pathway was followed for FDA clearance of the Radiographic Film Processor, Models XP400 and XP1000?

    The Radiographic Film Processor, Models XP400 and XP1000, received FDA clearance through a Traditional 510(k) pathway, specifically under clearance number K024342. The device was determined to be substantially equivalent to a legally marketed predicate and falls under regulation 892.1900, classified as a Processor, Radiographic-Film, Automatic.

  • What types of film does the Radiographic Film Processor, Models XP400 and XP1000, process, and how does it handle the film during development?

    The Radiographic Film Processor, Models XP400 and XP1000, is designed to process exposed sheet x-ray films. It uses a roller transport system to sequentially move the film through developer, fixer, and wash solutions, ensuring uniform and consistent processing throughout the entire batch.