510(k) K031385
K031385 is an FDA 510(k) premarket notification submitted by Anzai Medical Co., Ltd. for the device "ANZAI AZ-733 RESPIRATORY GATING SYSTEM". The FDA issued a decision of Substantially Equivalent on Nov 10, 2003. 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
- Nov 10, 2003
- Date Received
- May 1, 2003
- 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)