Cleared Traditional

K900062 - U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL

K900062 is an FDA 510(k) clearance for U.S.I. MODEL 1012, manufactured by U.S. Imaging, Inc.. The device is a Class 1 Radiology device with product code IZO cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K900062 · U.S. Imaging, Inc. · Radiology device
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Feb 1990
Decision
33d
Days
Class 1
Risk

K900062 is an FDA 510(k) clearance for the U.S.I. MODEL 1012, REMOTE FLUOROSCOPIC CONTROL. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by U.S. Imaging, Inc. (Greensburg, US). The FDA issued a Cleared decision on February 5, 1990 after a review of 33 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 U.S. Imaging, Inc. devices

FDA 510(k) Submission Details - K900062

510(k) Number K900062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1990
Decision Date February 05, 1990
Days to Decision 33 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 107d · This submission: 33d
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 K900062.
KXO-80C/80D
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