Cleared Traditional

K922443 - VERT-X UNIVERSAL VERTICAL BUCKY STAND (FDA 510(k) Clearance)

Class I Radiology device.

K922443 · Afp Imaging Corp. · Radiology device
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Oct 1992
Decision
157d
Days
Class 1
Risk

K922443 is an FDA 510(k) clearance for the VERT-X UNIVERSAL VERTICAL BUCKY STAND. Classified as Holder, Radiographic Cassette, Wall-mounted (product code IXY), Class I - General Controls.

Submitted by Afp Imaging Corp. (Elmsford, US). The FDA issued a Cleared decision on October 26, 1992 after a review of 157 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1880 - 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 Afp Imaging Corp. devices

Submission Details

510(k) Number K922443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1992
Decision Date October 26, 1992
Days to Decision 157 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 107d · This submission: 157d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IXY Holder, Radiographic Cassette, Wall-mounted
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1880
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.