Cleared Traditional

FlightPlan for Liver

K210807 · GE Medical Systems SCS · Radiology
Oct 2021
Decision
219d
Days
Class 2
Risk

About This 510(k) Submission

K210807 is an FDA 510(k) clearance for the FlightPlan for Liver, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on October 22, 2021, 219 days after receiving the submission on March 17, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K210807 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2021
Decision Date October 22, 2021
Days to Decision 219 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050