MRIdian Linac System with 138-leaf Collimator
FDA 510(k) K170751 · Viewray, Incorporated
510(k) numberK170751
Submission
- Device name
- MRIdian Linac System with 138-leaf Collimator
- Applicant
- Viewray, Incorporated
Oakwood Village, OH, US - Received
- March 13, 2017
- Decision date
- June 7, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|
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Questions and answers
When was MRIdian Linac System with 138-leaf Collimator cleared by the FDA?
MRIdian Linac System with 138-leaf Collimator (K170751) received a 510(k) decision of Substantially Equivalent on June 7, 2017, 86 days after the submission was received.
What is the product code of K170751?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.