Cleared Traditional

K922443 - VERT-X UNIVERSAL VERTICAL BUCKY STAND

K922443 is an FDA 510(k) clearance for VERT-X UNIVERSAL VERTICAL BUCKY STAND, manufactured by Afp Imaging Corp.. The device is a Class 1 Radiology device with product code IXY cleared through the Traditional 510(k) pathway after a 157-day FDA review.

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.

FDA 510(k) Submission Details - K922443

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 107d · This submission: 157d
Pathway characteristics
Predicate-based equivalence.

IXY Device Classification - Class 1, General Controls

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

All 20
Devices cleared under the same product code (IXY) and FDA review panel - the closest regulatory comparables to K922443.
BC/WT/PF
K930249 · Tingle X-Ray Products, Inc. · Apr 1993
WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT
K925934 · Continental X-Ray Corp. · Mar 1993
BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY
K924445 · Control-X, Inc. · Feb 1993
MODEL H170 PEDIATRIC CHEST X-RAY UNIT
K915667 · H.L. Lyons Co. · Jan 1992
BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C
K895034 · Yamato Medical Corp. · Nov 1989
RADKOR BS-10 AND BS-10T
K891395 · Radkor, Inc. · Apr 1989
K922443 · VERT-X UNIVERSAL VERTICAL BUCKY STAND
Download PDF Afp Imaging Corp.