Cleared Traditional

K955414 - XRT 400

K955414 is an FDA 510(k) clearance for XRT 400, manufactured by Wuestec Medical, Inc.. The device is a Class 2 Radiology device with product code KXJ cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K955414 · Wuestec Medical, Inc. · Radiology device
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Jul 1996
Decision
240d
Days
Class 2
Risk

K955414 is an FDA 510(k) clearance for the XRT 400. Classified as Table, Radiologic (product code KXJ), Class II - Special Controls.

Submitted by Wuestec Medical, Inc. (Mobile, US). The FDA issued a Cleared decision on July 24, 1996 after a review of 240 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 Wuestec Medical, Inc. devices

FDA 510(k) Submission Details - K955414

510(k) Number K955414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1995
Decision Date July 24, 1996
Days to Decision 240 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
133d slower than avg
Panel avg: 107d · This submission: 240d
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 15
Devices cleared under the same product code (KXJ) and FDA review panel - the closest regulatory comparables to K955414.
CARBON FIBER COUCH INSERT
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K931724 · Continental X-Ray Corp. · Jun 1993
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
REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100
K874639 · Shimadzu Precision Instruments, Inc. · Dec 1987