Cleared Traditional

K854328 - MEDEX X-RAY TABLE

K854328 is an FDA 510(k) clearance for MEDEX X-RAY TABLE, manufactured by Philips Medical Systems (Cleveland), Inc.. The device is a Class 2 Radiology device with product code KXJ cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K854328 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Jan 1986
Decision
92d
Days
Class 2
Risk

K854328 is an FDA 510(k) clearance for the MEDEX X-RAY TABLE. Classified as Table, Radiologic (product code KXJ), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on January 28, 1986 after a review of 92 days - within the typical 510(k) review window.

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 Philips Medical Systems (Cleveland), Inc. devices

FDA 510(k) Submission Details - K854328

510(k) Number K854328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date January 28, 1986
Days to Decision 92 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXJ Device Classification - Class 2, Special Controls

Product Code KXJ Table, Radiologic
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 - KXJ Table, Radiologic

All 17
Devices cleared under the same product code (KXJ) and FDA review panel - the closest regulatory comparables to K854328.
REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100
K874639 · Shimadzu Precision Instruments, Inc. · Dec 1987
OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER
K871827 · General Electric Co. · Jun 1987
SHAMPAINE RADI-OP MODEL 1700RC
K860620 · Smith & Nephew, Inc. · Apr 1986
SIEMENS SIRESKOP 4
K820111 · Siemens Corp. · Feb 1982
DUAL PEDESTAL TABLE
K811969 · Philips Medical Systems (Cleveland), Inc. · Aug 1981
ALLMEC 90/15
K811196 · Tecnomed, Inc. · Jun 1981