K121278 is an FDA 510(k) clearance for the HERMES MEDICAL IMAGING SUITE V5.2. This device is classified as a System, Tomography, Computed, Emission (Class II - Special Controls, product code KPS).
Submitted by Hermes Medical Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on December 18, 2012, 232 days after receiving the submission on April 30, 2012.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1200.
| 510(k) Number | K121278 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2012 |
| Decision Date | December 18, 2012 |
| Days to Decision | 232 days |
| Submission Type | Special |
| 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 |