Cleared Traditional

K860260 - MULTI PURPOSE MODEL 76-903 (FDA 510(k) Clearance)

Class I Radiology device.

K860260 · Victoreen, Inc. · Radiology device
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May 1986
Decision
103d
Days
Class 1
Risk

K860260 is an FDA 510(k) clearance for the MULTI PURPOSE MODEL 76-903. Classified as Instrument, Quality-assurance, Radiologic (product code LHO), Class I - General Controls.

Submitted by Victoreen, Inc. (Carle Place, US). The FDA issued a Cleared decision on May 7, 1986 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1940 - 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 Victoreen, Inc. devices

Submission Details

510(k) Number K860260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1986
Decision Date May 07, 1986
Days to Decision 103 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 107d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LHO Instrument, Quality-assurance, Radiologic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1940
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.