MRIdian Linac System
FDA 510(k) K181989 · Viewray, Incorporated
510(k) numberK181989
Submission
- Device name
- MRIdian Linac System
- Applicant
- Viewray, Incorporated
Mountain View, CA, US - Received
- July 26, 2018
- Decision date
- February 20, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Varian Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K212958 | MRIdian Linac SystemIYE · Traditional | 12/14/2021SE |
| K170751 | MRIdian Linac System with 138-leaf CollimatorIYE · Traditional | 06/07/2017SE |
| K162393 | The ViewRay (MRIdian) Linac SystemIYE · Traditional | 02/24/2017SE |
| K111862 | Viewray SystemIYE · Traditional | 05/22/2012SE |
| K102915 | Viewray Treatment Planning and Delivery SystemMUJ · Traditional | 01/12/2011SE |
Questions and answers
When was MRIdian Linac System cleared by the FDA?
MRIdian Linac System (K181989) received a 510(k) decision of Substantially Equivalent on February 20, 2019, 209 days after the submission was received.
What is the product code of K181989?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.