X-Sight Digital Imaging System
by Stallion Technologies, Inc.
510(k) K974134
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974134 | Date27 Jan 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The X-Sight Digital Imaging System is a fluoroscopic and radiographic digital imaging device designed for real-time X-ray imaging. It captures high-resolution digital images and video, enhancing diagnostic capabilities in interventional radiology, cardiology, and other fluoroscopy-dependent procedures. The system integrates with existing fluoroscopic and radiographic equipment to provide versatile imaging solutions for clinical workflows.
This device is supplied as a standalone imaging system and is intended for use in clinical settings such as hospitals and diagnostic imaging centers. It is not specified as single-use or reusable, though its digital nature suggests it is designed for repeated use in controlled environments. The system is FDA-cleared under 510(k) number K974134, with a clearance date of January 27, 1998. No additional sterility, MRI safety, or size specifications are provided in the available data.
Questions
AI-generated answers, 1 Oct 2026
What is the X-Sight Digital Imaging System used for?
The X-Sight Digital Imaging System is designed for real-time X-ray imaging in fluoroscopy-dependent procedures, such as interventional radiology and cardiology. It captures high-resolution digital images and video, improving diagnostic accuracy during complex interventions like angioplasty, stent placement, or vascular studies. Its integration with existing fluoroscopic and radiographic equipment makes it adaptable to clinical workflows in hospitals and diagnostic centers.
Is the X-Sight Digital Imaging System single-use or reusable?
The X-Sight Digital Imaging System is not specified as single-use or reusable in the provided data. However, its digital components and design suggest it is intended for repeated use in controlled clinical environments, where proper maintenance and calibration are essential for consistent performance.
What regulatory clearance does the X-Sight Digital Imaging System hold?
The X-Sight Digital Imaging System holds FDA clearance under the 510(k) process, with clearance number K974134. It was determined to be substantially equivalent to a legally marketed predicate device by the Radiology Advisory Committee and received clearance on January 27, 1998. This clearance allows it to be marketed in the U.S. for its intended uses.
How is the X-Sight Digital Imaging System supplied?
The X-Sight Digital Imaging System is supplied as a standalone imaging system, meaning it is not packaged as a disposable or single-use item. It is intended for installation and use in clinical settings like hospitals or diagnostic imaging centers, where it can be integrated with existing fluoroscopic and radiographic equipment to enhance procedural imaging capabilities.
Does the X-Sight Digital Imaging System require any special storage conditions?
The provided data does not specify special storage conditions for the X-Sight Digital Imaging System. However, as a medical imaging device, it should be stored in a clean, dry environment protected from physical damage, extreme temperatures, and electromagnetic interference. Regular maintenance and calibration, as recommended by the manufacturer, will ensure optimal performance and longevity.