K133719 is an FDA 510(k) clearance for the PDE-NEO. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Hamamatsu Photonics K.K. (Washington Dc, US). The FDA issued a Cleared decision on March 27, 2014, 112 days after receiving the submission on December 5, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K133719 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2013 |
| Decision Date | March 27, 2014 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZI - System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |