Cleared Traditional

K121200 - FLIGHTPLAN FOR LIVER

K121200 is the FDA 510(k) clearance for FLIGHTPLAN FOR LIVER by Ge Healthcare. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K121200 · Ge Healthcare · Radiology device
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Nov 2012
Decision
197d
Days
Class 2
Risk

K121200 is an FDA 510(k) clearance for the FLIGHTPLAN FOR LIVER. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Ge Healthcare (Wauwatosa, US). The FDA issued a Cleared decision on November 2, 2012 after a review of 197 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Ge Healthcare devices

Submission Details

510(k) Number K121200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2012
Decision Date November 02, 2012
Days to Decision 197 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 107d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1127
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K121200.
SCENIUM
K123528 · Siemens Medical Solutions USA, Inc. · Dec 2012
MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)
K123530 · Hologic, Inc. · Dec 2012
CENTRICITY PACS-IW WITH UNIVERSAL VIEWER
K123174 · Ge Healthcare · Nov 2012
VITREAADVANCED
K121213 · Vital Images, Inc. · Nov 2012
ECHONAVIGATOR RELEASE 1
K121781 · Philips Medical Systems Nederland B.V. · Oct 2012
CARESTREAM VUE PACS
K122523 · Carestream Health, Inc. · Oct 2012