Cleared Traditional

K950043 - JPI AUTOMATIC X-RAY FILM PROCESSOR

K950043 is an FDA 510(k) clearance for JPI AUTOMATIC X-RAY FILM PROCESSOR, manufactured by Jpi Healthcare Co, Ltd.. The device is a Class 2 Radiology device with product code IXW cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K950043 · Jpi Healthcare Co, Ltd. · Radiology device
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May 1995
Decision
125d
Days
Class 2
Risk

K950043 is an FDA 510(k) clearance for the JPI AUTOMATIC X-RAY FILM PROCESSOR. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Jpi Healthcare Co, Ltd. (Bayside, US). The FDA issued a Cleared decision on May 10, 1995 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1900 - 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 - K950043

510(k) Number K950043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1995
Decision Date May 10, 1995
Days to Decision 125 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
18d slower than avg
Panel avg: 107d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXW Device Classification - Class 2, Special Controls

Product Code IXW Processor, Radiographic-film, Automatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1900
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IXW Processor, Radiographic-film, Automatic

All 43
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K950043.
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FUJI COMPUTED RADIOGRAPHY SYSTEMS
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KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS
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FUJI MEDICAL FILM PROCESSOR FPM2800
K935957 · Fujifilm Medical System U.S.A., Inc. · Jan 1994