Cleared Traditional

HYDRADJUST IV UROLOGICAL TABLE (K943581) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 76
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
X-RAY TABLE
K914165 · Siemens Medical Solutions USA, Inc. · Nov 1991
SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE
K882019 · General Electric Co. · May 1988
SIREGRAPH D
K860913 · Siemens Medical Solutions USA, Inc. · Apr 1986
TABLE, X-RAY, RFX CLASSICAL
K760466 · General Electric Co. · Aug 1976