510(k) K063691
- Device
- NEUTRON THERAPY SYSTEM
- Applicant
- Northern Illinois Univ. Outreach
- 510(k) number
- K063691
- Product code
- IWL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-01-31
- Date received
- 2006-12-12
- Regulation
- 892.5300
- Classification name
- System, Radiation Therapy, Neutron, Medical
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- JONATHAN S KAHAN
- Address
- 555 Thirteenth St. NW Washington DC US 20004 20004