K946053 is an FDA 510(k) clearance for the SIMVIEW(TM) 3000. This device is classified as a System, Simulation, Radiation Therapy (Class II - Special Controls, product code KPQ).
Submitted by Siemens Medical Solutions USA, Inc. (Concord, US). The FDA issued a Cleared decision on March 31, 1995, 109 days after receiving the submission on December 12, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5840.
| 510(k) Number | K946053 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 1994 |
| Decision Date | March 31, 1995 |
| Days to Decision | 109 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 |