510(k) K181676
K181676 is an FDA 510(k) premarket notification submitted by Hitachi Ltd. Healthcare Hitachi Works for the device "Mini Ridge Filter and auxiliary functions for PROBEAT-V". The FDA issued a decision of Substantially Equivalent on August 15, 2018. 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
- August 15, 2018
- Date Received
- June 25, 2018
- 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