K091658 is an FDA 510(k) clearance for the GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Ge Healthcare (Waukesha, US). The FDA issued a Cleared decision on June 29, 2009, 20 days after receiving the submission on June 9, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K091658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2009 |
| Decision Date | June 29, 2009 |
| Days to Decision | 20 days |
| Submission Type | Special |
| 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 |