Cleared Traditional

FlightPlan for Embolization

K193261 · GE Medical Systems SCS · Radiology
Jan 2020
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K193261 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 January 24, 2020, 59 days after receiving the submission on November 26, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K193261 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2019
Decision Date January 24, 2020
Days to Decision 59 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