510(k) K132847
K132847 is an FDA 510(k) premarket notification submitted by Ion Beam Applications S.A. for the device "I2C". The FDA issued a decision of Substantially Equivalent on November 20, 2013. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050. Ion Beam Applications S.A. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2013
- Date Received
- September 11, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Radiation Therapy, Charged-Particle, Medical
- Device Class
- Class II
- Regulation Number
- 892.5050
- Review Panel
- RA
- Submission Type