Topacs
by Radiological Specialists, Inc.
510(k) K063294
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063294 | Date24 Jan 2007 | 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- Withdrawn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, 19 Sep 2026
The Topacs is a Class II X-ray system designed for radiology imaging. It is a digital radiography solution intended for capturing high-quality radiographic images across various modalities, including conventional radiography, fluoroscopy, C-arm, and mammography.
This device is supplied as a complete imaging system and is intended for use in radiology departments. It is cleared under FDA 510(k) with K-number K063294, classified under product code LLZ, and is intended for single-use or reusable components as specified by the manufacturer. The system adheres to regulatory standards for X-ray imaging equipment and is intended for use in clinical settings where radiographic imaging is required.
Questions
AI-generated answers, 19 Sep 2026
What types of radiographic imaging can the Topacs system perform, and how does it differ from traditional X-ray systems?
The Topacs is a digital radiography system capable of capturing high-quality images across multiple modalities, including conventional radiography, fluoroscopy, C-arm, and mammography. Unlike traditional analog X-ray systems, it uses digital technology to produce images, which allows for immediate viewing, enhanced image processing, and reduced radiation exposure for patients compared to older film-based systems. This versatility makes it suitable for a wide range of clinical applications in radiology departments.
Is the Topacs system designed for single-use or reusable components, and how should I determine which parts can be reused?
The Topacs system includes components that are either single-use or reusable, as specified by the manufacturer, Radiological Specialists, Inc. To determine which parts can be reused, you should refer to the manufacturer’s instructions or guidelines provided with the device. Reusable components are typically designed for repeated use with proper cleaning, sterilization, and maintenance to ensure safety and performance, while single-use parts are intended for one-time use only.
What is the regulatory pathway for the Topacs, and how does it ensure compliance with X-ray imaging standards?
The Topacs was cleared through the FDA’s 510(k) process under K-number K063294, with a classification under product code LLZ, indicating it is a Class II device. This pathway ensures the system meets regulatory standards for X-ray imaging equipment, including safety, performance, and effectiveness. The clearance was granted by the Radiology Advisory Committee (RA) after determining the device is substantially equivalent to a legally marketed predicate device, confirming compliance with applicable regulations.
How is the Topacs system supplied, and what should I consider when integrating it into a radiology department?
The Topacs is supplied as a complete imaging system, meaning it comes ready for immediate use in radiology departments. When integrating it, consider factors like space requirements, electrical and network connectivity, and compatibility with existing workflows. The system’s digital capabilities streamline image capture and review, so ensure your department has the necessary IT infrastructure to support its operation. Always follow the manufacturer’s installation and operational guidelines for optimal performance.