Cleared Traditional

K943581 - HYDRADJUST IV UROLOGICAL TABLE

K943581 is an FDA 510(k) clearance for HYDRADJUST IV UROLOGICAL TABLE, manufactured by Mallinckrodt Group, Inc.. The device is a Class 2 Radiology device with product code IXR cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K943581 · Mallinckrodt Group, Inc. · Radiology device
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Jan 1995
Decision
166d
Days
Class 2
Risk

K943581 is an FDA 510(k) clearance for the HYDRADJUST IV UROLOGICAL TABLE. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Mallinckrodt Group, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 4, 1995 after a review of 166 days - an extended review 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: 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 Mallinckrodt Group, Inc. devices

FDA 510(k) Submission Details - K943581

510(k) Number K943581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1994
Decision Date January 04, 1995
Days to Decision 166 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
59d slower than avg
Panel avg: 107d · This submission: 166d
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 47
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K943581.
COMPAX 90/15E
K954356 · General Electric Co. · Oct 1995
KOORDINAT M
K951176 · Siemens Medical Solutions USA, Inc. · Apr 1995
MOBILIX MOBILE X-RAY TABLE
K945842 · GE Medical Systems · Jan 1995
URO - ELITE TABLE ACCESSORIES
K944987 · Philips Medical Systems (Cleveland), Inc. · Nov 1994
CLINIX VP 4 TABLE
K940721 · Philips Medical Systems (Cleveland), Inc. · May 1994
UROLOGICAL C-ARM TABLE, MODEL #056-450
K922591 · Biodan Medical Systems, Ltd. · Nov 1992