Cleared Traditional

K062059 - AIE REGION OF INTEREST IMAGE ENHANCEMENT

K062059 is an FDA 510(k) clearance for AIE REGION OF INTEREST IMAGE ENHANCEMENT, manufactured by Advanced Image Enhancement. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K062059 · Advanced Image Enhancement · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
48d
Days
Class 2
Risk

K062059 is an FDA 510(k) clearance for the AIE REGION OF INTEREST IMAGE ENHANCEMENT. 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 Advanced Image Enhancement (Monroe, US). The FDA issued a Cleared decision on September 6, 2006 after a review of 48 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 Advanced Image Enhancement devices

FDA 510(k) Submission Details - K062059

510(k) Number K062059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2006
Decision Date September 06, 2006
Days to Decision 48 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 107d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

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 1412
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K062059.
EP NAVIGATOR SOFTWARE
K062650 · Philips Medical Systems · Sep 2006
CTC WORKSTATION, MODEL 2200
K062229 · Medical Diagnostic Technologies, Inc. · Sep 2006
XCELERA
K061995 · Philips Medical Systems North America Co. · Sep 2006
CORONIS 3MP AND MDCG 3120-CB
K061924 · Barcoview · Sep 2006
CORONIS COLOR 3MP AND MDCC 3120-DL
K061927 · Barcoview · Sep 2006
CORONIS COLOR 2MP AND MDCC 2121
K061928 · Barcoview · Sep 2006