Cleared Traditional

K041782 - SEEMOR 5.0 IMAGE DISPLAY PROGRAM

K041782 is an FDA 510(k) clearance for SEEMOR 5.0 IMAGE DISPLAY PROGRAM, manufactured by Areeda Assoc., Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K041782 · Areeda Assoc., Ltd. · Radiology device
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Aug 2004
Decision
46d
Days
Class 2
Risk

K041782 is an FDA 510(k) clearance for the SEEMOR 5.0 IMAGE DISPLAY PROGRAM. 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 Areeda Assoc., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on August 16, 2004 after a review of 46 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 Areeda Assoc., Ltd. devices

FDA 510(k) Submission Details - K041782

510(k) Number K041782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2004
Decision Date August 16, 2004
Days to Decision 46 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
61d faster than avg
Panel avg: 107d · This submission: 46d
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 1308
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