Cleared Traditional

K895969 - RADKOR DXG-650R

K895969 is an FDA 510(k) clearance for RADKOR DXG-650R, manufactured by Radkor, Inc.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K895969 · Radkor, Inc. · Radiology device
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Nov 1989
Decision
32d
Days
Class 1
Risk

K895969 is an FDA 510(k) clearance for the RADKOR DXG-650R. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Radkor, Inc. (Irvine, US). The FDA issued a Cleared decision on November 13, 1989 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1700 - 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 - K895969

510(k) Number K895969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1989
Decision Date November 13, 1989
Days to Decision 32 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 107d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

IZO Device Classification - Class 1, General Controls

Product Code IZO Generator, High-voltage, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1700
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IZO Generator, High-voltage, X-ray, Diagnostic

All 100
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K895969.
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