K912466 is an FDA 510(k) clearance for the OLDELFT SIMULIX-MC. This device is classified as a System, Simulation, Radiation Therapy (Class II - Special Controls, product code KPQ).
Submitted by Oldelft Corp. of America (Fairfax, US). The FDA issued a Cleared decision on June 28, 1991, 24 days after receiving the submission on June 4, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5840.
| 510(k) Number | K912466 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 1991 |
| Decision Date | June 28, 1991 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | KPQ — System, Simulation, Radiation Therapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5840 |