Cleared Traditional

FlightPlan for Embolization

K223490 · GE Medical Systems SCS · Radiology
Mar 2023
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K223490 is an FDA 510(k) clearance for the FlightPlan for Embolization, 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 March 21, 2023, 120 days after receiving the submission on November 21, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K223490 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2022
Decision Date March 21, 2023
Days to Decision 120 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