Cleared Traditional

K913121 - OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108...

K913121 is an FDA 510(k) clearance for OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108..., 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 31-day FDA review.

K913121 · Continental X-Ray Corp. · Radiology device
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Aug 1991
Decision
31d
Days
Class 2
Risk

K913121 is an FDA 510(k) clearance for the OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400. 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 August 16, 1991 after a review of 31 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 - K913121

510(k) Number K913121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1991
Decision Date August 16, 1991
Days to Decision 31 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
76d faster than avg
Panel avg: 107d · This submission: 31d
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 K913121.
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
OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER
K871827 · General Electric Co. · Jun 1987
SHAMPAINE RADI-OP MODEL 1700RC
K860620 · Smith & Nephew, Inc. · Apr 1986
MEDEX X-RAY TABLE
K854328 · Philips Medical Systems (Cleveland), Inc. · Jan 1986