K193152 is an FDA 510(k) clearance for the Affinity. 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 February 14, 2020, 93 days after receiving the submission on November 13, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1200.
| 510(k) Number | K193152 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2019 |
| Decision Date | February 14, 2020 |
| Days to Decision | 93 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 |