K133705 is an FDA 510(k) clearance for the REVOLUTION CT. This device is classified as a System, X-ray, Tomography, Computed (Class II - Special Controls, product code JAK).
Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on April 11, 2014, 129 days after receiving the submission on December 3, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750.
| 510(k) Number | K133705 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2013 |
| Decision Date | April 11, 2014 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAK — System, X-ray, Tomography, Computed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1750 |