Cleared Traditional

K954161 - JPI INTENSIFYING SCREEN (FDA 510(k) Clearance)

Class I Radiology device.

K954161 · Jpi Healthcare Co, Ltd. · Radiology device
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Feb 1996
Decision
150d
Days
Class 1
Risk

K954161 is an FDA 510(k) clearance for the JPI INTENSIFYING SCREEN. Classified as Screen, Intensifying, Radiographic (product code EAM), Class I - General Controls.

Submitted by Jpi Healthcare Co, Ltd. (Bayside, US). The FDA issued a Cleared decision on February 2, 1996 after a review of 150 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 Jpi Healthcare Co, Ltd. devices

Submission Details

510(k) Number K954161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1995
Decision Date February 02, 1996
Days to Decision 150 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 107d · This submission: 150d
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.