Konica Srx- 701 Automatic X-Ray Film Processor
by Konica Medical Corp. 510(k)
Active
510(k) K990969
Overview
The Konica SRX-701 Automatic X-Ray Film Processor is a Class II medical device classified as an automatic radiographic-film processor. It is designed to automatically develop, fix, wash, and dry radiographic film used in X-ray imaging, ensuring high-quality diagnostic images for radiology applications. The system processes film through precise chemical baths and mechanical transport to produce clear, usable radiographic results.
This device is intended for use in radiology departments within healthcare facilities. It operates as a reusable, non-sterile system, adhering to FDA clearance under the 510(k) pathway (K990969) with a product code of IXW. The processor follows regulatory standards outlined in 21 CFR 892.1900 and is supplied as a standalone unit for integration into existing X-ray workflows. No MRI safety or sterility requirements are specified for this device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990969 | Date18 Jun 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 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 is the Konica SRX-701 Automatic X-Ray Film Processor used for?
The Konica SRX-701 is designed to automatically develop, fix, wash, and dry radiographic film used in X-ray imaging. It ensures high-quality diagnostic images by processing film through precise chemical baths and mechanical transport, making it essential for radiology departments in healthcare facilities.
Is the Konica SRX-701 Automatic X-Ray Film Processor reusable or single-use?
The Konica SRX-701 is a reusable system, meaning it is intended for repeated use within radiology departments. It is not classified as single-use, and its design supports integration into existing X-ray workflows for long-term operation.
What are the sterility and safety requirements for the Konica SRX-701?
The Konica SRX-701 is a non-sterile device and does not require MRI safety certification. It adheres to FDA regulatory standards outlined in 21 CFR 892.1900, ensuring compliance for use in radiology settings without additional sterility constraints.
How is the Konica SRX-701 supplied, and what is its regulatory status?
The Konica SRX-701 is supplied as a standalone unit, ready for integration into existing X-ray workflows. It holds FDA clearance under the 510(k) pathway (K990969) and is classified as a Class II medical device, with a product code of IXW.
What are the key specifications or distinguishing features of the Konica SRX-701?
The device is classified under OpenFDA as an automatic radiographic-film processor (device_name) with a focus on radiology applications. It follows a substantially equivalent decision (SESE) under the FDA’s 510(k) review process, ensuring it meets regulatory standards for automatic film processing in diagnostic imaging.