510(k) K170719
K170719 is an FDA 510(k) premarket notification submitted by Anzai Medical Co., Ltd. for the device "Anzai Respiratory Gating System". The FDA issued a decision of Substantially Equivalent on Apr 5, 2017. The device falls under product code LHN (System, Radiation Therapy, Charged-Particle, Medical), a Class II device regulated under 21 CFR 892.5050. Anzai Medical Co., Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 5, 2017
- Date Received
- Mar 9, 2017
- Clearance Type
- Special
- 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)