510(k) K171049
K171049 is an FDA 510(k) premarket notification submitted by Hitachi, Ltd. Healthcare for the device "Real Time Image Gating System for Proton Beam Therapy Systems". The FDA issued a decision of Substantially Equivalent on Dec 26, 2017. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 26, 2017
- Date Received
- Apr 7, 2017
- 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
- 510(k)