Cleared Traditional

K912799 - EAGLE SYSTEM (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K912799 · Marquette Electronics, Inc. · Radiology device
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Dec 1991
Decision
176d
Days
Class 2
Risk

K912799 is an FDA 510(k) clearance for the EAGLE SYSTEM. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on December 18, 1991 after a review of 176 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2040 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Marquette Electronics, Inc. devices

Submission Details

510(k) Number K912799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1991
Decision Date December 18, 1991
Days to Decision 176 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 107d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LMC Camera, Multi Format, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2040
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.