Cleared Traditional

K954161 - JPI INTENSIFYING SCREEN

K954161 is an FDA 510(k) clearance for JPI INTENSIFYING SCREEN, manufactured by Jpi Healthcare Co, Ltd.. The device is a Class 1 Radiology device with product code EAM cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K954161 · Jpi Healthcare Co, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K954161

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.

EAM Device Classification - Class 1, General Controls

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.

Regulatory Peers - EAM Screen, Intensifying, Radiographic

All 27
Devices cleared under the same product code (EAM) and FDA review panel - the closest regulatory comparables to K954161.
KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC
K943821 · Fujifilm Medical System U.S.A., Inc. · Aug 1994
FUJI UM MAMMO SERIES INTENSIFY SCREENS:
K943822 · Fujifilm Medical System U.S.A., Inc. · Aug 1994
FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12
K943823 · Fujifilm Medical System U.S.A., Inc. · Aug 1994
KYOKKO GREEN SERIES INTENSIFYING SCREENS
K942235 · Fujifilm Medical System U.S.A., Inc. · Aug 1994
FUJI HG-M INTENSIFYING SCREEN
K943425 · Fujifilm Medical System U.S.A., Inc. · Aug 1994
KYOKKO BLUE SERIES INTENSIFYING SCREENS
K942805 · Fujifilm Medical System U.S.A., Inc. · Jul 1994