Cleared Traditional

K130069 - INNOVA EPVISION 2.0

K130069 is the FDA 510(k) clearance for INNOVA EPVISION 2.0 by Ge Healthcare. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K130069 · Ge Healthcare · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
84d
Days
Class 2
Risk

K130069 is an FDA 510(k) clearance for the INNOVA EPVISION 2.0, INNOVA EPVISION 2.0. 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 (Buc, FR). The FDA issued a Cleared decision on April 5, 2013 after a review of 84 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. 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 K130069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2013
Decision Date April 05, 2013
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
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 K130069.
CORONIS 3MP
K131246 · Barco N.V. · May 2013
4D VIEW
K131118 · Ge Healthcare · May 2013
SYNAPSE 3D CARDIAC TOOLS
K130383 · Fujifilm Medical System U.S.A., Inc. · Apr 2013
5MP MONOCHROME LCD MONITOR, RADIFORCE GX540
K130336 · Eizo Nanao Corporation · Mar 2013
NOBELCLINICIAN
K123976 · Nobel Biocare AB · Mar 2013
VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
K122578 · Vital Images, Inc. · Feb 2013