Cleared Traditional

K901014 - RADIOGRAPHIC INTENSIFYING SCREEN (FDA 510(k) Clearance)

Class I Radiology device.

K901014 · Infab Corp. · Radiology device
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Apr 1990
Decision
28d
Days
Class 1
Risk

K901014 is an FDA 510(k) clearance for the RADIOGRAPHIC INTENSIFYING SCREEN. Classified as Screen, Intensifying, Radiographic (product code EAM), Class I - General Controls.

Submitted by Infab Corp. (Camarillo, US). The FDA issued a Cleared decision on April 2, 1990 after a review of 28 days - a notably fast clearance 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: 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 Infab Corp. devices

Submission Details

510(k) Number K901014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1990
Decision Date April 02, 1990
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
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.