Cleared Traditional

K860504 - 36-101 XDS111 XENON DELIVERY/TRAP SYSTEM (FDA 510(k) Clearance)

Class I Radiology device.

K860504 · Victoreen, Inc. · Radiology device
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Apr 1986
Decision
52d
Days
Class 1
Risk

K860504 is an FDA 510(k) clearance for the 36-101 XDS111 XENON DELIVERY/TRAP SYSTEM. Classified as Assembly, Tube Housing, X-ray, Diagnostic (product code ITY), Class I - General Controls.

Submitted by Victoreen, Inc. (Carle Place, US). The FDA issued a Cleared decision on April 4, 1986 after a review of 52 days - a notably fast clearance cycle.

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: 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 Victoreen, Inc. devices

Submission Details

510(k) Number K860504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1986
Decision Date April 04, 1986
Days to Decision 52 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 107d · This submission: 52d
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.