510(k) K033339
K033339 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY". The FDA issued a decision of Substantially Equivalent on December 30, 2003. The device falls under product code KPQ (System, Simulation, Radiation Therapy), a Class II device regulated under 21 CFR 892.5840. Varian Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 2003
- Date Received
- October 17, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Simulation, Radiation Therapy
- Device Class
- Class II
- Regulation Number
- 892.5840
- Review Panel
- RA
- Submission Type