The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Flightplan For Embolization.
| Device ID | K193261 |
| 510k Number | K193261 |
| Device Name: | FlightPlan For Embolization |
| Classification | System, Image Processing, Radiological |
| Applicant | GE Medical Systems SCS 283, Rue De La Miniere Buc, FR 78530 |
| Contact | Ning Wen |
| Correspondent | Ning Wen GE Medical Systems SCS 283, Rue De La Miniere Buc, FR 78530 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-26 |
| Decision Date | 2020-01-24 |