K964138 is an FDA 510(k) clearance for the VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE. This device is classified as a System, Simulation, Radiation Therapy (Class II - Special Controls, product code KPQ).
Submitted by Varian Medical Systems, Inc. (Crawley, West Sussex, GB). The FDA issued a Cleared decision on January 10, 1997, 87 days after receiving the submission on October 15, 1996.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5840.
| 510(k) Number | K964138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1996 |
| Decision Date | January 10, 1997 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPQ — System, Simulation, Radiation Therapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5840 |