Cleared Traditional

K925934 - WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT (FDA 510(k) Clearance)

Class I Radiology device.

K925934 · Continental X-Ray Corp. · Radiology device
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Mar 1993
Decision
104d
Days
Class 1
Risk

K925934 is an FDA 510(k) clearance for the WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT. Classified as Holder, Radiographic Cassette, Wall-mounted (product code IXY), Class I - General Controls.

Submitted by Continental X-Ray Corp. (Broadview, US). The FDA issued a Cleared decision on March 4, 1993 after a review of 104 days - within the typical 510(k) review window.

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 Continental X-Ray Corp. devices

Submission Details

510(k) Number K925934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1992
Decision Date March 04, 1993
Days to Decision 104 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
3d faster than avg
Panel avg: 107d · This submission: 104d
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.