K181403 is an FDA 510(k) clearance for the Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR. This device is classified as a Interventional Fluoroscopic X-ray System (Class II - Special Controls, product code OWB).
Submitted by Ge Healthcare (Buc, FR). The FDA issued a Cleared decision on November 2, 2018, 157 days after receiving the submission on May 29, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650. Interventional Fluoroscopy.
| 510(k) Number | K181403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2018 |
| Decision Date | November 02, 2018 |
| Days to Decision | 157 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 |