K061028 is an FDA 510(k) clearance for the PRECISION THUNIS 800+. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II - Special Controls, product code JAA).
Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on June 7, 2006, 55 days after receiving the submission on April 13, 2006.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K061028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2006 |
| Decision Date | June 07, 2006 |
| Days to Decision | 55 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 |