K130269 is an FDA 510(k) clearance for the ECAT SCINTRON PET. This device is classified as a System, Tomography, Computed, Emission (Class II - Special Controls, product code KPS).
Submitted by Miegmbh (Seth, DE). The FDA issued a Cleared decision on April 19, 2013, 74 days after receiving the submission on February 4, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1200.
| 510(k) Number | K130269 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2013 |
| Decision Date | April 19, 2013 |
| Days to Decision | 74 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 |