Cleared Traditional

MODIF TOP DRIVE BOARD CXT-90 90/90 DIAG TILT TABLE (K912996) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K912996 · Continental X-Ray Corp. · Radiology device
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Feb 1992
Decision
210d
Days
Class 2
Risk

K912996 is an FDA 510(k) clearance for the MODIF TOP DRIVE BOARD CXT-90 90/90 DIAG TILT TABLE. Classified as Table, Radiographic, Tilting (product code IXR), Class II - Special Controls.

Submitted by Continental X-Ray Corp. (Broadview, US). The FDA issued a Cleared decision on February 3, 1992 after a review of 210 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 Continental X-Ray Corp. devices

Submission Details

510(k) Number K912996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1991
Decision Date February 03, 1992
Days to Decision 210 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
103d slower than avg
Panel avg: 107d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IXR Table, Radiographic, Tilting
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 - IXR Table, Radiographic, Tilting

All 11
Devices cleared under the same product code (IXR) and FDA review panel - the closest regulatory comparables to K912996.
URO - ELITE TABLE ACCESSORIES
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CLINIX VP 4 TABLE
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K922364 · Toshiba America Medical Systems, In.C · Sep 1992
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K914165 · Siemens Medical Solutions USA, Inc. · Nov 1991
SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE
K882019 · General Electric Co. · May 1988
SIREGRAPH D
K860913 · Siemens Medical Solutions USA, Inc. · Apr 1986