Cleared Traditional

K913062 - SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10

K913062 is an FDA 510(k) clearance for SHIMADZU X-RAY HIGH VOLTAGE GENERATOR U..., manufactured by Shimadzu Medical Systems. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K913062 · Shimadzu Medical Systems · Radiology device
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Sep 1991
Decision
68d
Days
Class 1
Risk

K913062 is an FDA 510(k) clearance for the SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B-10. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Shimadzu Medical Systems (Gardena, US). The FDA issued a Cleared decision on September 16, 1991 after a review of 68 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 Shimadzu Medical Systems devices

FDA 510(k) Submission Details - K913062

510(k) Number K913062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1991
Decision Date September 16, 1991
Days to Decision 68 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
39d faster than avg
Panel avg: 107d · This submission: 68d
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 99
Devices cleared under the same product code (IZO) and FDA review panel - the closest regulatory comparables to K913062.
MICRO-X 50 HF
K914236 · Fischer Imaging Corp. · Nov 1991
MICRO-X 30 HF
K914266 · Fischer Imaging Corp. · Nov 1991
EDITOR MP 800/HF-850 X-RAY CONTROL AND GENERATOR
K911562 · Continental X-Ray Corp. · Oct 1991
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD150B-10
K913063 · Shimadzu Medical Systems · Sep 1991
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR XUD 150L
K913064 · Shimadzu Medical Systems · Sep 1991
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150L
K913065 · Shimadzu Medical Systems · Sep 1991