Cleared Traditional

K963905 - RADIOGRAPHIC ITT TABLE

K963905 is an FDA 510(k) clearance for RADIOGRAPHIC ITT TABLE, manufactured by X-Ray Technologies, Inc.. The device is a Class 2 Radiology device with product code KXJ cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K963905 · X-Ray Technologies, Inc. · Radiology device
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Nov 1996
Decision
43d
Days
Class 2
Risk

K963905 is an FDA 510(k) clearance for the RADIOGRAPHIC ITT TABLE. Classified as Table, Radiologic (product code KXJ), Class II - Special Controls.

Submitted by X-Ray Technologies, Inc. (Skokie, US). The FDA issued a Cleared decision on November 12, 1996 after a review of 43 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 X-Ray Technologies, Inc. devices

FDA 510(k) Submission Details - K963905

510(k) Number K963905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1996
Decision Date November 12, 1996
Days to Decision 43 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
64d faster than avg
Panel avg: 107d · This submission: 43d
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 K963905.
APOLLO
K050190 · Villa Sistemi Medicali S.P.A. · Mar 2005
XRT 400
K955414 · Wuestec Medical, Inc. · Jul 1996
CARBON FIBER COUCH INSERT
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SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5
K940696 · Philips Medical Systems North America, Inc. · Mar 1994
ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES
K931724 · Continental X-Ray Corp. · Jun 1993
CAG-02A
K922098 · Toshiba America Medical Systems, In.C · Jul 1992