K202392 is an FDA 510(k) clearance for the SIR-Spheres Microspheres Activity Calculator (SMAC). This device is classified as a System, Tomography, Computed, Emission (Class II - Special Controls, product code KPS).
Submitted by Sirtex Medical US Holdings, Inc. (Woburn, US). The FDA issued a Cleared decision on October 23, 2020, 63 days after receiving the submission on August 21, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1200.
| 510(k) Number | K202392 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2020 |
| Decision Date | October 23, 2020 |
| Days to Decision | 63 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 |