Cleared Traditional

K931724 - ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES

K931724 is an FDA 510(k) clearance for ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES, manufactured by Continental X-Ray Corp.. The device is a Class 2 Radiology device with product code KXJ cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K931724 · Continental X-Ray Corp. · Radiology device
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Jun 1993
Decision
82d
Days
Class 2
Risk

K931724 is an FDA 510(k) clearance for the ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES. Classified as Table, Radiologic (product code KXJ), Class II - Special Controls.

Submitted by Continental X-Ray Corp. (Broadview, US). The FDA issued a Cleared decision on June 14, 1993 after a review of 82 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 Continental X-Ray Corp. devices

FDA 510(k) Submission Details - K931724

510(k) Number K931724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1993
Decision Date June 14, 1993
Days to Decision 82 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 107d · This submission: 82d
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 12
Devices cleared under the same product code (KXJ) and FDA review panel - the closest regulatory comparables to K931724.
CARBON FIBER COUCH INSERT
K950068 · Medtec, Inc. · Apr 1995
SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5
K940696 · Philips Medical Systems North America, Inc. · Mar 1994
CAG-02A
K922098 · Toshiba America Medical Systems, In.C · Jul 1992
OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400
K913121 · Continental X-Ray Corp. · Aug 1991
OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER
K871827 · General Electric Co. · Jun 1987
SHAMPAINE RADI-OP MODEL 1700RC
K860620 · Smith & Nephew, Inc. · Apr 1986