Varian Unique Single Energy Linear Accelerator
by Varian Medical Systems, Oncology Systems
510(k) K101751
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101751 | Date10 Aug 2010 | StatusActive |
Recalls
-
- Terminated Z-0483-2012
An event has been reported to Varian which entails excessive connector resistance, which caused the actual jaw positions to differ from the intended jaw positions without warning the operator.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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, 28 Sep 2026
The Varian Unique Single Energy Linear Accelerator is a medical linear accelerator device used for delivering radiation therapy. It is designed for stereotactic radiosurgery and precision radiotherapy to treat lesions, tumors, and conditions throughout the body where radiation treatment is indicated.
This device is supplied as a reusable system and operates using a magnetron for beam generation and a clutch drive mechanism. It has received FDA 510(k) clearance (K101751) and is classified as a Class II medical device under regulation number 892.5050, with product code IYE. The device is manufactured by Varian Medical Systems, Oncology Systems and is intended for use in clinical radiotherapy settings.