K113708 is an FDA 510(k) clearance for the ORTHOSCAN MOBILE DI MINI C-ARM. This device is classified as a Image-intensified Fluoroscopic X-ray System, Mobile (Class II - Special Controls, product code OXO).
Submitted by Orthoscan, Inc. (Scottsdale, US). The FDA issued a Cleared decision on January 5, 2012, 20 days after receiving the submission on December 16, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Fluoroscopy Of The Human Body..
| 510(k) Number | K113708 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2011 |
| Decision Date | January 05, 2012 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| 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. |