The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Ge Discovery Igs Angiographic,fluoroscopic X-ray System.
| Device ID | K113403 |
| 510k Number | K113403 |
| Device Name: | GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE MEDICAL SYSTEMS SCS 283 RUE DE LA MINIERE Buc, FR 78530 |
| Contact | Michel Genuer |
| Correspondent | Michel Genuer GE MEDICAL SYSTEMS SCS 283 RUE DE LA MINIERE Buc, FR 78530 |
| Product Code | OWB |
| Subsequent Product Code | IZI |
| Subsequent Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-17 |
| Decision Date | 2012-02-14 |
| Summary: | summary |