Cleared Traditional

K874946 - SHIMADZU X-RAY HIGH VOLTAGE GENERATOR H...

K874946 is an FDA 510(k) clearance for SHIMADZU X-RAY HIGH VOLTAGE GENERATOR H..., manufactured by Shimadzu Precision Instruments, Inc.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 92-day FDA review.

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

FDA 510(k) Submission Details - K874946

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 107d · This submission: 92d
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 96
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