K160131 is an FDA 510(k) clearance for the OEC Elite MiniView. This device is classified as a Image-intensified Fluoroscopic X-ray System, Mobile (Class II - Special Controls, product code OXO).
Submitted by Ge Hangwei Medical Systems Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on June 21, 2016, 153 days after receiving the submission on January 20, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Fluoroscopy Of The Human Body..
| 510(k) Number | K160131 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 2016 |
| Decision Date | June 21, 2016 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OXO - Image-intensified Fluoroscopic X-ray System, Mobile |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Fluoroscopy Of The Human Body. |