K103038 is an FDA 510(k) clearance for the DUET DRF. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA).
Submitted by Cmt Medical Technologies, Ltd. (Yoqneam Ilit, IL). The FDA issued a Cleared decision on March 29, 2011, 166 days after receiving the submission on October 14, 2010.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K103038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 2010 |
| Decision Date | March 29, 2011 |
| Days to Decision | 166 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAA — System, X-ray, Fluoroscopic, Image-intensified |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1650 |