Cleared Traditional

K024028 - SHARP VIEW IMAGE ENHANCEMENT SYSTEM

K024028 is an FDA 510(k) clearance for SHARP VIEW IMAGE ENHANCEMENT SYSTEM, manufactured by Context Vision AB. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K024028 · Context Vision AB · Radiology device
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Jan 2003
Decision
49d
Days
Class 2
Risk

K024028 is an FDA 510(k) clearance for the SHARP VIEW IMAGE ENHANCEMENT SYSTEM. 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 Context Vision AB (Linkoping, SE). The FDA issued a Cleared decision on January 24, 2003 after a review of 49 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 Context Vision AB devices

FDA 510(k) Submission Details - K024028

510(k) Number K024028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2002
Decision Date January 24, 2003
Days to Decision 49 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
58d faster than avg
Panel avg: 107d · This submission: 49d
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 1460
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K024028.
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