Cleared Traditional

K090546 - MODIFICATION TO NORDICICE SOFTWARE

K090546 is an FDA 510(k) clearance for MODIFICATION TO NORDICICE SOFTWARE, manufactured by Nordicimaginglab AS. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K090546 · Nordicimaginglab AS · Radiology device
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Jun 2009
Decision
98d
Days
Class 2
Risk

K090546 is an FDA 510(k) clearance for the MODIFICATION TO NORDICICE SOFTWARE. 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 Nordicimaginglab AS (Bergen, Hordaland, NO). The FDA issued a Cleared decision on June 8, 2009 after a review of 98 days - within the typical 510(k) review window.

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 Nordicimaginglab AS devices

FDA 510(k) Submission Details - K090546

510(k) Number K090546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2009
Decision Date June 08, 2009
Days to Decision 98 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
9d faster than avg
Panel avg: 107d · This submission: 98d
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.

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All 1330
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