510(k) K102915
K102915 is an FDA 510(k) premarket notification submitted by Viewray, Incorporated for the device "VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 12, 2011. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Viewray, Incorporated has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 12, 2011
- Date Received
- Oct 1, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Planning, Radiation Therapy Treatment
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type
- 510(k)