K121418 is an FDA 510(k) clearance for the PLANMED VERITY. This device is classified as a System, X-ray, Tomography, Computed (Class II - Special Controls, product code JAK).
Submitted by Planmed OY (Helsinki, FI). The FDA issued a Cleared decision on February 1, 2013, 266 days after receiving the submission on May 11, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1750.
| 510(k) Number | K121418 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2012 |
| Decision Date | February 01, 2013 |
| Days to Decision | 266 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 |