Cleared Traditional

K874946 - SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60 (FDA 510(k) Clearance)

Class I Radiology device.

K874946 · Shimadzu Precision Instruments, Inc. · Radiology device
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Mar 1988
Decision
92d
Days
Class 1
Risk

K874946 is an FDA 510(k) clearance for the SHIMADZU X-RAY HIGH VOLTAGE GENERATOR HD150G-60. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Shimadzu Precision Instruments, Inc. (Torrance, US). The FDA issued a Cleared decision on March 3, 1988 after a review of 92 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 Precision Instruments, Inc. devices

Submission Details

510(k) Number K874946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1987
Decision Date March 03, 1988
Days to Decision 92 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 107d · This submission: 92d
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.