X-Ray Film Processor
510(k) K940112
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK940112 | Date11 Apr 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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, 1 Oct 2026
This device is an Automatic Radiographic-Film Processor (Device Class II), designed to chemically develop, fix, and dry radiographic film for diagnostic imaging. It processes X-ray film to produce visible images for radiologic examination, ensuring consistent film quality through automated chemical processing. The processor adheres to regulatory standards for radiographic film development, including temperature and timing controls to optimize image clarity and diagnostic accuracy.
The X-Ray Film Processor is intended for use in radiology departments, dental offices, and podiatric or orthodontic clinics where X-ray imaging is performed. Supplied as a reusable medical device, it requires proper maintenance and calibration to ensure reliable performance. The processor is not MRI-safe and must be stored in a controlled environment, protected from extreme temperatures and humidity. Authorized for commercial distribution in the U.S. under FDA 510K clearance (K940112), it complies with regulatory requirements for radiographic film processing equipment.
Other devices from Fischer Industries, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Fischer X-Ray Film Processor used for?
The Fischer X-Ray Film Processor is designed to chemically develop, fix, and dry radiographic film for diagnostic imaging. It ensures high-quality, consistent X-ray images by automating the processing steps, which is essential for accurate radiologic examinations in settings like radiology departments, dental offices, and podiatric or orthodontic clinics.
Is the Fischer X-Ray Film Processor reusable or single-use?
This device is a reusable medical instrument. It requires regular maintenance and calibration to maintain reliable performance and image quality. Proper care extends its operational lifespan while ensuring compliance with radiographic standards.
What environmental conditions are required for storage?
The processor must be stored in a controlled environment, protected from extreme temperatures and humidity. This prevents degradation of chemical solutions and mechanical components, ensuring consistent processing performance and image quality over time.
Can this device be used in an MRI environment?
No, the Fischer X-Ray Film Processor is explicitly not MRI-safe. It should only be used in non-MRI settings, such as radiology departments or dental offices, where magnetic resonance imaging is not performed.
What regulatory clearance does this device hold?
The Fischer X-Ray Film Processor holds FDA 510K clearance under the reference number K940112, with a decision date of April 11, 1995. This clearance confirms it meets U.S. regulatory standards for automatic radiographic-film processing equipment in Class II medical devices.