K101013 is an FDA 510(k) clearance for the MODIFICATION TO SCINTRON IV. This device is classified as a System, Tomography, Computed, Emission (Class II - Special Controls, product code KPS).
Submitted by Miegmbh (Elk Grove Village, US). The FDA issued a Cleared decision on June 7, 2010, 56 days after receiving the submission on April 12, 2010.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1200.
| 510(k) Number | K101013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2010 |
| Decision Date | June 07, 2010 |
| Days to Decision | 56 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 |