Cleared Traditional

K860760 - ERBIUM X-RAY FILTER

K860760 is an FDA 510(k) clearance for ERBIUM X-RAY FILTER, manufactured by Reactor Experiments, Inc.. The device is a Class 1 Radiology device with product code ITY cleared through the Traditional 510(k) pathway after a 102-day FDA review.

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

FDA 510(k) Submission Details - K860760

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.

ITY Device Classification - Class 1, General Controls

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.

Regulatory Peers - ITY Assembly, Tube Housing, X-ray, Diagnostic

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