Cleared Traditional

K844578 - NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONA (FDA 510(k) Clearance)

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

K844578 · Engineering Dynamics Corp. · Radiology device
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May 1985
Decision
172d
Days
Class 2
Risk

K844578 is an FDA 510(k) clearance for the NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONA. Classified as Stretcher, Wheeled (product code FPO), Class II - Special Controls.

Submitted by Engineering Dynamics Corp. (Lowell, US). The FDA issued a Cleared decision on May 14, 1985 after a review of 172 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 880.6910 - 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 Engineering Dynamics Corp. devices

Submission Details

510(k) Number K844578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1984
Decision Date May 14, 1985
Days to Decision 172 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 107d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPO Stretcher, Wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6910
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.