Cleared Traditional

K850198 - FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND (FDA 510(k) Clearance)

Also includes:
RADIOG

Class I Radiology device.

K850198 · Summit Industries, Inc. · Radiology device
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May 1985
Decision
116d
Days
Class 1
Risk

K850198 is an FDA 510(k) clearance for the FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND. Classified as Tube Mount, X-ray, Diagnostic (product code IYB), Class I - General Controls.

Submitted by Summit Industries, Inc. (Chicago, US). The FDA issued a Cleared decision on May 14, 1985 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1770 - 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 Summit Industries, Inc. devices

Submission Details

510(k) Number K850198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1985
Decision Date May 14, 1985
Days to Decision 116 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 107d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IYB Tube Mount, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1770
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.