Cleared Traditional

K951146 - IMAGING TABLE

K951146 is an FDA 510(k) clearance for IMAGING TABLE, manufactured by Septa Corp.. The device is a Class 2 Radiology device with product code KXJ cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K951146 · Septa Corp. · Radiology device
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May 1995
Decision
52d
Days
Class 2
Risk

K951146 is an FDA 510(k) clearance for the IMAGING TABLE. Classified as Table, Radiologic (product code KXJ), Class II - Special Controls.

Submitted by Septa Corp. (Mason, US). The FDA issued a Cleared decision on May 4, 1995 after a review of 52 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 Septa Corp. devices

FDA 510(k) Submission Details - K951146

510(k) Number K951146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1995
Decision Date May 04, 1995
Days to Decision 52 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
55d faster than avg
Panel avg: 107d · This submission: 52d
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 18
Devices cleared under the same product code (KXJ) and FDA review panel - the closest regulatory comparables to K951146.
APOLLO
K050190 · Villa Sistemi Medicali S.P.A. · Mar 2005
RADIOGRAPHIC ITT TABLE
K963905 · X-Ray Technologies, Inc. · Nov 1996
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K950068 · Medtec, Inc. · Apr 1995
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K940696 · Philips Medical Systems North America, Inc. · Mar 1994
ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES
K931724 · Continental X-Ray Corp. · Jun 1993