Cleared Traditional

K090481 - DEMASQ IMAGING SPFTWARE DEVICE

K090481 is an FDA 510(k) clearance for DEMASQ IMAGING SPFTWARE DEVICE, manufactured by Demasq Limited. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K090481 · Demasq Limited · Radiology device
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Mar 2009
Decision
23d
Days
Class 2
Risk

K090481 is an FDA 510(k) clearance for the DEMASQ IMAGING SPFTWARE DEVICE. 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 Demasq Limited (Cardiff Wales, GB). The FDA issued a Cleared decision on March 19, 2009 after a review of 23 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 Demasq Limited devices

FDA 510(k) Submission Details - K090481

510(k) Number K090481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2009
Decision Date March 19, 2009
Days to Decision 23 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 1333
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