Viewray Treatment Planning and Delivery System
FDA 510(k) K102915 · Viewray, Incorporated
510(k) numberK102915
Submission
- Device name
- Viewray Treatment Planning and Delivery System
- Applicant
- Viewray, Incorporated
Oakwood Village, OH, US - Received
- October 1, 2010
- Decision date
- January 12, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Viewray Treatment Planning and Delivery System cleared by the FDA?
Viewray Treatment Planning and Delivery System (K102915) received a 510(k) decision of Substantially Equivalent on January 12, 2011, 103 days after the submission was received.
What is the product code of K102915?
The FDA product code is MUJ – System, Planning, Radiation Therapy Treatment, a Class II (moderate risk) device regulated under 21 CFR 892.5050.