K113403 is an FDA 510(k) clearance for the GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on February 14, 2012, 89 days after receiving the submission on November 17, 2011.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K113403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2011 |
| Decision Date | February 14, 2012 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | OWB — Interventional Fluoroscopic X-ray System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |
| Definition | Interventional Fluoroscopy |