K052345 is an FDA 510(k) clearance for the ADVANTAGE SIM MD. This device is classified as a System, Simulation, Radiation Therapy (Class II - Special Controls, product code KPQ).
Submitted by Ge Healthcare (Waukesha, US). The FDA issued a Cleared decision on September 14, 2005, 19 days after receiving the submission on August 26, 2005.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5840.
| 510(k) Number | K052345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2005 |
| Decision Date | September 14, 2005 |
| Days to Decision | 19 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 |