Cleared Traditional

K803162 - X-RAY STAND & OPERATING CHAIR (FDA 510(k) Clearance)

Class I Radiology device.

K803162 · Downs Surgical , Ltd. · Radiology device
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Jan 1981
Decision
146d
Days
Class 1
Risk

K803162 is an FDA 510(k) clearance for the X-RAY STAND & OPERATING CHAIR. Classified as Tube Mount, X-ray, Diagnostic (product code IYB), Class I - General Controls.

Submitted by Downs Surgical , Ltd. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1981 after a review of 146 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 Downs Surgical , Ltd. devices

Submission Details

510(k) Number K803162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1980
Decision Date January 28, 1981
Days to Decision 146 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 107d · This submission: 146d
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.