Konica Qx-130APLUS Automatic X-Ray Film Processor
by Konica Medical Corp. 510(k)
Active
510(k) K931313
Overview
The Konica QX-130A Plus Automatic X-Ray Film Processor is an Automatic Processor, Radiographic-Film (per FDA classification IXW, regulation 892.1900). This device is designed to chemically develop and process radiographic film cassettes automatically, producing high-quality diagnostic images for radiology applications. It handles film processing through precise chemical baths, ensuring consistent exposure and contrast for medical imaging. The system is classified as a Class II medical device under FDA regulations, requiring premarket notification (510(k)) clearance.
The processor is intended for use in radiology departments, hospitals, or clinical settings where X-ray imaging is performed. It operates as a reusable, non-sterile device, requiring proper maintenance and calibration to maintain performance standards. The device is not MRI-compatible and must be stored in a controlled environment to protect against contamination and mechanical damage. Authorized for commercial distribution in the U.S. via FDA 510(k) clearance (K931313), it adheres to regulatory requirements for automatic radiographic film processing systems.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK931313 | Date7 Sep 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
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
Other devices from Konica Medical Corp.
Questions
What types of medical facilities would benefit most from using the Konica QX-130A Plus Automatic X-Ray Film Processor, and why?
The Konica QX-130A Plus is designed for radiology departments, hospitals, or clinical settings where X-ray imaging is performed. It automates the chemical development of radiographic film cassettes, ensuring high-quality, consistent diagnostic images—ideal for environments where traditional film processing is still used alongside digital systems. Its precision and reliability make it particularly useful in high-volume settings where efficiency and image quality are critical.
Is the Konica QX-130A Plus Automatic X-Ray Film Processor intended for single-use or reusable applications, and what maintenance does it require?
The device is explicitly designed as a reusable, non-sterile system, requiring regular maintenance and calibration to sustain performance standards. Since it processes radiographic film cassettes through chemical baths, proper upkeep—including chemical replenishment, equipment cleaning, and mechanical checks—is essential to avoid degradation in image quality or system failure.
What storage conditions should be followed for the Konica QX-130A Plus to ensure optimal performance and longevity?
The processor must be stored in a controlled environment to prevent contamination and mechanical damage. This includes protection from dust, moisture, extreme temperatures, and physical impacts. Since it is not MRI-compatible, it should also be kept away from electromagnetic interference sources, as these could affect its functionality or the quality of processed films.
How does the Konica QX-130A Plus differ from modern digital X-ray systems, and what role does it play in current radiology workflows?
Unlike digital X-ray systems, the Konica QX-130A Plus processes radiographic film cassettes using automated chemical development, producing physical film images rather than digital data. It remains relevant in hybrid workflows where film is still used for specific diagnostic needs—such as certain types of contrast studies or archival purposes—while digital systems handle routine imaging. Its role is to provide high-resolution, analog images when required, complementing digital radiography.