Cleared Traditional

K860760 - ERBIUM X-RAY FILTER (FDA 510(k) Clearance)

Class I Radiology device.

K860760 · Reactor Experiments, Inc. · Radiology device
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Jun 1986
Decision
102d
Days
Class 1
Risk

K860760 is an FDA 510(k) clearance for the ERBIUM X-RAY FILTER. Classified as Assembly, Tube Housing, X-ray, Diagnostic (product code ITY), Class I - General Controls.

Submitted by Reactor Experiments, Inc. (San Carlos, US). The FDA issued a Cleared decision on June 10, 1986 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1760 - 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 Reactor Experiments, Inc. devices

Submission Details

510(k) Number K860760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1986
Decision Date June 10, 1986
Days to Decision 102 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 107d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ITY Assembly, Tube Housing, X-ray, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1760
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.