The following data is part of a premarket notification filed by Ge Medical Systems Scs with the FDA for Flightplan For Liver.
Device ID | K210807 |
510k Number | K210807 |
Device Name: | FlightPlan For Liver |
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 | 2021-03-17 |
Decision Date | 2021-10-22 |