Cleared Traditional

K840227 - UROLIX-3 UROLOGICAL TABLE

K840227 is an FDA 510(k) clearance for UROLIX-3 UROLOGICAL TABLE, manufactured by Medicor USA , Ltd.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K840227 · Medicor USA , Ltd. · Radiology device
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Mar 1984
Decision
64d
Days
Class 2
Risk

K840227 is an FDA 510(k) clearance for the UROLIX-3 UROLOGICAL TABLE. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Medicor USA , Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1980 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medicor USA , Ltd. devices

FDA 510(k) Submission Details - K840227

510(k) Number K840227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1984
Decision Date March 23, 1984
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXR Device Classification - Class 2, Special Controls

Product Code IXR Table, Radiographic, Tilting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1980
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 - IXR Table, Radiographic, Tilting

All 48
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K840227.
SIREGRAPH D
K860913 · Siemens Medical Solutions USA, Inc. · Apr 1986
OMNI PLANE SYSTEM
K854085 · Xre Corp. · Oct 1985
PRESTILIX 1690
K843926 · Cgr Medical Corp. · Dec 1984
HILO TRANS-X TRAUMA TRANSPORT
K792326 · Tecnomed, Inc. · Jan 1980
TRIOSKOP
K792645 · Siemens Corp. · Jan 1980
UROSKOP A AND B
K781532 · Siemens Corp. · Sep 1978