Cleared Traditional

K844337 - X-RAY TUBESTANDS BUCKY STANDS & VETERINARY X-RAY

K844337 is an FDA 510(k) clearance for X-RAY TUBESTANDS BUCKY STANDS & VETERIN..., manufactured by Quality X-Ray Manufacturing, Inc.. The device is a Class 1 Radiology device with product code IYB cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K844337 · Quality X-Ray Manufacturing, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
105d
Days
Class 1
Risk

K844337 is an FDA 510(k) clearance for the X-RAY TUBESTANDS BUCKY STANDS & VETERINARY X-RAY. Classified as Tube Mount, X-ray, Diagnostic (product code IYB), Class I - General Controls.

Submitted by Quality X-Ray Manufacturing, Inc. (Memphis, US). The FDA issued a Cleared decision on February 21, 1985 after a review of 105 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 Quality X-Ray Manufacturing, Inc. devices

FDA 510(k) Submission Details - K844337

510(k) Number K844337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1984
Decision Date February 21, 1985
Days to Decision 105 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 107d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

IYB Device Classification - Class 1, General Controls

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.

Regulatory Peers - IYB Tube Mount, X-ray, Diagnostic

All 21
Devices cleared under the same product code (IYB) and FDA review panel - the closest regulatory comparables to K844337.
CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX
K880530 · Fischer Imaging Corp. · Mar 1988
OVERHEAD TUBE MOUNT CASCADE II
K880528 · Fischer Imaging Corp. · Feb 1988
TRAUMA STAND
K852952 · Xre Corp. · Sep 1985
AP X-RAY TUBE ANGULATION DEVICE
K811970 · Philips Medical Systems (Cleveland), Inc. · Aug 1981
ARGOSTAT
K811195 · Tecnomed, Inc. · Jun 1981
X-RAY STAND & OPERATING CHAIR
K803162 · Downs Surgical , Ltd. · Jan 1981