K133259 is an FDA 510(k) clearance for the YSIO MAX. This device is classified as a System, X-ray, Stationary (Class II - Special Controls, product code KPR).
Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on January 24, 2014, 93 days after receiving the submission on October 23, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.
| 510(k) Number | K133259 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 2013 |
| Decision Date | January 24, 2014 |
| Days to Decision | 93 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPR — System, X-ray, Stationary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1680 |