Cleared Traditional

K883431 - RAYMAX 2100 MODELS 2130 & 2136 (FDA 510(k) Clearance)

Class I Radiology device.

K883431 · Raymax Medical Corp. · Radiology device
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Sep 1988
Decision
28d
Days
Class 1
Risk

K883431 is an FDA 510(k) clearance for the RAYMAX 2100 MODELS 2130 & 2136. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Raymax Medical Corp. (Ontario, L4l 7k5, CA). The FDA issued a Cleared decision on September 12, 1988 after a review of 28 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 Raymax Medical Corp. devices

Submission Details

510(k) Number K883431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1988
Decision Date September 12, 1988
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.