Cleared Traditional

K854478 - REI-90/90 RADIOGRAPHIC TABLE (FDA 510(k) Clearance)

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

K854478 · Radiological Engineering, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
161d
Days
Class 2
Risk

K854478 is an FDA 510(k) clearance for the REI-90/90 RADIOGRAPHIC TABLE. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Radiological Engineering, Inc. (North Ft. Myers, US). The FDA issued a Cleared decision on April 17, 1986 after a review of 161 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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 Radiological Engineering, Inc. devices

Submission Details

510(k) Number K854478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1985
Decision Date April 17, 1986
Days to Decision 161 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 107d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXR Table, Radiographic, Tilting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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.