510(k) K063691
K063691 is an FDA 510(k) premarket notification submitted by Northern Illinois Univ. Outreach for the device "NEUTRON THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on January 31, 2007. The device falls under product code IWL (System, Radiation Therapy, Neutron, Medical), a Class II device regulated under 21 CFR 892.5300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2007
- Date Received
- December 12, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Radiation Therapy, Neutron, Medical
- Device Class
- Class II
- Regulation Number
- 892.5300
- Review Panel
- RA
- Submission Type