K113408 is an FDA 510(k) clearance for the Q. FREEZE (MOTION VUE2). This device is classified as a System, Tomography, Computed, Emission (Class II - Special Controls, product code KPS).
Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on February 24, 2012, 98 days after receiving the submission on November 18, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1200.
| 510(k) Number | K113408 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2011 |
| Decision Date | February 24, 2012 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPS — System, Tomography, Computed, Emission |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1200 |