Cleared Traditional

K854486 - TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE (FDA 510(k) Clearance)

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

K854486 · Absolute X-Ray Corp. · Radiology device
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Jan 1986
Decision
64d
Days
Class 2
Risk

K854486 is an FDA 510(k) clearance for the TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Absolute X-Ray Corp. (Long Island City, US). The FDA issued a Cleared decision on January 10, 1986 after a review of 64 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Absolute X-Ray Corp. devices

Submission Details

510(k) Number K854486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1985
Decision Date January 10, 1986
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
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.