Cleared Traditional

RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE (K924443) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924443 · Control-X, Inc. · Radiology device
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Feb 1993
Decision
157d
Days
Class 2
Risk

K924443 is an FDA 510(k) clearance for the RS-3 UNIVERSAL RADIOGRAPHIC WORKING PLACE. Classified as System, X-ray, Tomographic (product code IZF), Class II - Special Controls.

Submitted by Control-X, Inc. (Columbus, US). The FDA issued a Cleared decision on February 5, 1993 after a review of 157 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1740 - 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 K924443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date February 05, 1993
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. No clinical trials required.

Device Classification

Product Code IZF System, X-ray, Tomographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZF System, X-ray, Tomographic

All 13
Devices cleared under the same product code (IZF) and FDA review panel - the closest regulatory comparables to K924443.
DR 600 with Tomosynthesis
K193262 · Agfa N.V. · Mar 2020
DR 800 with Tomosynthesis
K183275 · Agfa N.V. · Feb 2019
TOMO-LINK
K944967 · GE Medical Systems · Dec 1994
CLINIX-R TOMOGRAPHIC DEVICE
K810274 · Philips Medical Systems (Cleveland), Inc. · Mar 1981
VTX (GE CATAOLG NO. B7005A)
K792067 · General Electric Co. · Dec 1979
ORBITOME-UG
K780319 · Philips Medical Systems (Cleveland), Inc. · Mar 1978