Cleared Traditional

K760568 - SINGLE PHASE X-RAY CONTROLS & HV GENERATORS (FDA 510(k) Clearance)

Class I Radiology device.

K760568 · Litton Medical Systems · Radiology device
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Sep 1976
Decision
13d
Days
Class 1
Risk

K760568 is an FDA 510(k) clearance for the SINGLE PHASE X-RAY CONTROLS & HV GENERATORS. Classified as Generator, High-voltage, X-ray, Diagnostic (product code IZO), Class I - General Controls.

Submitted by Litton Medical Systems (Mchenry, US). The FDA issued a Cleared decision on September 15, 1976 after a review of 13 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 Litton Medical Systems devices

Submission Details

510(k) Number K760568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1976
Decision Date September 15, 1976
Days to Decision 13 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 107d · This submission: 13d
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.