Cleared Traditional

K862414 - FUJI CR IMAGING PLATE (FDA 510(k) Clearance)

Class I Radiology device.

K862414 · Parexel Intl. Corp. · Radiology device
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Feb 1987
Decision
246d
Days
Class 1
Risk

K862414 is an FDA 510(k) clearance for the FUJI CR IMAGING PLATE. Classified as Screen, Intensifying, Radiographic (product code EAM), Class I - General Controls.

Submitted by Parexel Intl. Corp. (Cambridge, US). The FDA issued a Cleared decision on February 26, 1987 after a review of 246 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1960 - 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 Parexel Intl. Corp. devices

Submission Details

510(k) Number K862414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1986
Decision Date February 26, 1987
Days to Decision 246 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 107d · This submission: 246d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EAM Screen, Intensifying, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1960
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.