Cleared Traditional

BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY (K924445) - FDA 510(k) Clearance

Class I Radiology device.

K924445 · Control-X, Inc. · Radiology device
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Feb 1993
Decision
171d
Days
Class 1
Risk

K924445 is an FDA 510(k) clearance for the BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY. Classified as Holder, Radiographic Cassette, Wall-mounted (product code IXY), Class I - General Controls.

Submitted by Control-X, Inc. (Columbus, US). The FDA issued a Cleared decision on February 19, 1993 after a review of 171 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 Control-X, Inc. devices

Submission Details

510(k) Number K924445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date February 19, 1993
Days to Decision 171 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
64d slower than avg
Panel avg: 107d · This submission: 171d
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.

Regulatory Peers - IXY Holder, Radiographic Cassette, Wall-mounted

Devices cleared under the same product code (IXY) and FDA review panel - the closest regulatory comparables to K924445.
VRS 3 WALL STAND
K953336 · Philips Medical Systems (Cleveland), Inc. · Aug 1995
UNIVERSIX 190
K953402 · Philips Medical Systems (Cleveland), Inc. · Aug 1995
MULTI-SIZE CASSETTE HOLDER
K850125 · Philips Medical Systems (Cleveland), Inc. · Mar 1985
WALL CASSETTE HOLDER - TRAC44
K810194 · Philips Medical Systems (Cleveland), Inc. · Feb 1981