LinacView
510(k) K172534
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK172534 | Date27 Oct 2017 | 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- Withdrawn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
- Full name
- LINACwatch, LinacView
- 510(k) Number
- FDA Product Code
- IYE
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
LinacView is a Class II medical device software designed as a standalone solution for analyzing the performance of linear accelerators (LINACs) used in radiation therapy. It functions as a real-time monitoring tool, processing log files generated during treatment sessions to assess beam delivery accuracy and machine performance metrics.
The device operates in a radiology setting, interfacing with log files from Varian and Elekta linear accelerators to provide automated, background analysis of treatment fractions. Supplied as a software-only solution, it requires no sterilization or physical handling, adhering to FDA 510(k) clearance (K172534) under regulatory classification IYE. No third-party involvement is indicated, and its use is confined to quality assurance and performance validation of LINAC systems.
Questions
AI-generated answers, 1 Oct 2026
What is LinacView used for in radiation therapy?
LinacView is a software tool designed to monitor and analyze the performance of linear accelerators (LINACs) during radiation therapy sessions. It processes log files generated by Varian and Elekta LINACs to assess beam delivery accuracy and machine performance metrics in real time. This helps clinicians validate treatment fractions and ensures consistent, high-quality radiation delivery for patients.
How is LinacView supplied and does it require sterilization?
LinacView is supplied exclusively as a software-only solution. Since it operates digitally and does not involve physical handling or sterilization processes, there are no sterilization requirements. The device is intended for use in radiology settings where it interfaces directly with existing LINAC log files.
Is LinacView a single-use or reusable device?
LinacView is not a physical device requiring reuse or disposal. As a standalone software solution, it is installed on a system and continuously analyzes log files from LINACs. There is no concept of single-use or reuse—it remains functional as long as the underlying infrastructure and software licenses are maintained.
Which LINAC models does LinacView support?
LinacView is compatible with log files from Varian and Elekta linear accelerators. While the device itself does not require physical connection to the LINAC, it relies on the log data generated during treatment sessions from these specific brands. The software processes these logs to provide performance insights without needing direct hardware integration.
How should LinacView be stored or maintained?
Since LinacView is a software solution, storage involves maintaining the system environment where it is installed—such as a dedicated workstation or server in the radiology department. Regular software updates and system maintenance (e.g., hardware upgrades, network stability) are necessary to ensure continued functionality. No physical storage or preservation methods apply, as the device operates entirely through digital analysis.