The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Ge Innova/innova Igs/discovery Igs/optima Angiographic, Fluoscopic X-ray Systems With Cathlab Frontiers Solutions.
| Device ID | K122457 |
| 510k Number | K122457 |
| Device Name: | GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | GE HEALTHCARE 283, RUE DE LA MINIERE Buc, FR 78530 |
| Contact | Malca |
| Correspondent | Malca GE HEALTHCARE 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 | 2012-08-13 |
| Decision Date | 2013-01-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682121637 | K122457 | 000 |
| 00840682108621 | K122457 | 000 |
| 00840682108638 | K122457 | 000 |
| 00840682110129 | K122457 | 000 |
| 00840682110648 | K122457 | 000 |
| 00840682110662 | K122457 | 000 |
| 00840682110693 | K122457 | 000 |
| 00840682110709 | K122457 | 000 |
| 00840682117975 | K122457 | 000 |
| 00840682118002 | K122457 | 000 |
| 00840682124614 | K122457 | 000 |
| 00840682124621 | K122457 | 000 |
| 00840682124638 | K122457 | 000 |
| 00840682104739 | K122457 | 000 |