The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Flightplan For Liver.
Device ID | K121200 |
510k Number | K121200 |
Device Name: | FLIGHTPLAN FOR LIVER |
Classification | System, Image Processing, Radiological |
Applicant | GE HEALTHCARE 9900 W INNOVATION DR Wauwatosa, WI 53226 -4856 |
Contact | Carol Alloian |
Correspondent | Carol Alloian GE HEALTHCARE 9900 W INNOVATION DR Wauwatosa, WI 53226 -4856 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-19 |
Decision Date | 2012-11-02 |
Summary: | summary |