Cleared Traditional

K883885 - RADKOR, RF-159

K883885 is an FDA 510(k) clearance for RADKOR, manufactured by Radkor, Inc.. The device is a Class 2 Radiology device with product code KXJ cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K883885 · Radkor, Inc. · Radiology device
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Oct 1988
Decision
36d
Days
Class 2
Risk

K883885 is an FDA 510(k) clearance for the RADKOR, RF-159. Classified as Table, Radiologic (product code KXJ), Class II - Special Controls.

Submitted by Radkor, Inc. (Irvine, US). The FDA issued a Cleared decision on October 19, 1988 after a review of 36 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 Radkor, Inc. devices

FDA 510(k) Submission Details - K883885

510(k) Number K883885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1988
Decision Date October 19, 1988
Days to Decision 36 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 107d · This submission: 36d
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 K883885.
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K874639 · Shimadzu Precision Instruments, Inc. · Dec 1987
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K871827 · General Electric Co. · Jun 1987
SHAMPAINE RADI-OP MODEL 1700RC
K860620 · Smith & Nephew, Inc. · Apr 1986