K082243 is an FDA 510(k) clearance for the PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by General Medical Merate S.P.A (Colorado, US). The FDA issued a Cleared decision on November 7, 2008, 92 days after receiving the submission on August 7, 2008.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K082243 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2008 |
| Decision Date | November 07, 2008 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | OWB — Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |