Cleared Traditional

K861019 - CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD (FDA 510(k) Clearance)

Class I Radiology device.

K861019 · Phase One Disign Co. · Radiology device
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Apr 1986
Decision
15d
Days
Class 1
Risk

K861019 is an FDA 510(k) clearance for the CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD. Classified as Screen, Leaded, Operator Radiation Protector (product code EAK), Class I - General Controls.

Submitted by Phase One Disign Co. (San Rafael, US). The FDA issued a Cleared decision on April 2, 1986 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.6500 - 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 Phase One Disign Co. devices

Submission Details

510(k) Number K861019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1986
Decision Date April 02, 1986
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EAK Screen, Leaded, Operator Radiation Protector
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.6500
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.