Cleared Traditional

K933471 - SHIMADZU X-RAY HIGH VOLTAGE GENERATOR A...

K933471 is the FDA 510(k) clearance for SHIMADZU X-RAY HIGH VOLTAGE GENERATOR A... by Shimadzu Corp.. It is a Class 1 Radiology device (product code IZO) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K933471 · Shimadzu Corp. · Radiology device
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Nov 1993
Decision
132d
Days
Class 1
Risk

K933471 is an FDA 510(k) clearance for the SHIMADZU X-RAY HIGH VOLTAGE GENERATOR AUD150G. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Shimadzu Corp. (Kyoto City 604 Japan, JP). The FDA issued a Cleared decision on November 24, 1993 after a review of 132 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shimadzu Corp. devices

Submission Details

510(k) Number K933471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1993
Decision Date November 24, 1993
Days to Decision 132 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 107d · This submission: 132d
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.

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

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