Cleared Traditional

K850117 - XMA 325 (X-RAY GENERATOR) (FDA 510(k) Clearance)

Class I Radiology device.

K850117 · Summit Industries, Inc. · Radiology device
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Apr 1985
Decision
85d
Days
Class 1
Risk

K850117 is an FDA 510(k) clearance for the XMA 325 (X-RAY GENERATOR). Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Summit Industries, Inc. (Chicago, US). The FDA issued a Cleared decision on April 9, 1985 after a review of 85 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 Summit Industries, Inc. devices

Submission Details

510(k) Number K850117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date April 09, 1985
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
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.