Cleared Traditional

K915227 - GEN-X 800/500

K915227 is an FDA 510(k) clearance for GEN-X 800/500, manufactured by Swiss Ray Medical Systems. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K915227 · Swiss Ray Medical Systems · Radiology device
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Jan 1992
Decision
50d
Days
Class 1
Risk

K915227 is an FDA 510(k) clearance for the GEN-X 800/500. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Swiss Ray Medical Systems (Mobile, US). The FDA issued a Cleared decision on January 9, 1992 after a review of 50 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 Swiss Ray Medical Systems devices

FDA 510(k) Submission Details - K915227

510(k) Number K915227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1991
Decision Date January 09, 1992
Days to Decision 50 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 107d · This submission: 50d
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 K915227.
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