Cleared Special

GE ECHOPAC (K120221) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K120221 · Ge Healthcare · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
65d
Days
Class 2
Risk

K120221 is an FDA 510(k) clearance for the GE ECHOPAC. 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 March 30, 2012 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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 K120221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2012
Decision Date March 30, 2012
Days to Decision 65 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 107d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

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 730
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K120221.
SYNGO.MR NEUROLOGY
K121459 · Siemens Medical Solutions USA, Inc. · Jun 2012
SCENIUM 2.0
K121074 · Siemens Medical Solutions USA, Inc. · Jun 2012
SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION
K120315 · Siemens Medical Solutions USA, Inc. · Apr 2012
VIEW 1 IMAGING
K112480 · KARL STORZ Endoscopy-America, Inc. · Dec 2011
SYNGO VIA MI WORKFLOWS
K113029 · Siemens Medical Solutions USA, Inc. · Nov 2011
AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE
K103308 · KARL STORZ Endoscopy-America, Inc. · Aug 2011