Cleared Traditional

K081987 - UNISYN IMAGE FUSION

K081987 is an FDA 510(k) clearance for UNISYN IMAGE FUSION, manufactured by Convergent Imaging Solutions. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K081987 · Convergent Imaging Solutions · Radiology device
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Sep 2008
Decision
74d
Days
Class 2
Risk

K081987 is an FDA 510(k) clearance for the UNISYN IMAGE FUSION, VERSION 1.0. 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 Convergent Imaging Solutions (Ottawa, Ontario, CA). The FDA issued a Cleared decision on September 26, 2008 after a review of 74 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 Convergent Imaging Solutions devices

FDA 510(k) Submission Details - K081987

510(k) Number K081987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2008
Decision Date September 26, 2008
Days to Decision 74 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
33d faster than avg
Panel avg: 107d · This submission: 74d
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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