Cleared Traditional

K945328 - JPI X-RAY FILM CASSETTE

K945328 is an FDA 510(k) clearance for JPI X-RAY FILM CASSETTE, manufactured by Jpi America, Inc.. The device is a Class 2 Radiology device with product code IXA cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K945328 · Jpi America, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
80d
Days
Class 2
Risk

K945328 is an FDA 510(k) clearance for the JPI X-RAY FILM CASSETTE. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Jpi America, Inc. (Bayside, US). The FDA issued a Cleared decision on January 20, 1995 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1850 - 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.

FDA 510(k) Submission Details - K945328

510(k) Number K945328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1994
Decision Date January 20, 1995
Days to Decision 80 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 107d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXA Device Classification - Class 2, Special Controls

Product Code IXA Cassette, Radiographic Film
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1850
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 - IXA Cassette, Radiographic Film

All 49
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K945328.
CRONEX LOW ABSORPTION CASSETTE
K952891 · The DU Pont Co. · Jul 1995
KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)
K951006 · Kenex , Ltd. · Apr 1995
X-RAY FILM CASSETTE
K945858 · J.P.I. Chicago Co. · Mar 1995
MCI OPTONIX CASSETTE OKAMOTO CASSETE
K945039 · Mci Optonix, Inc. · Nov 1994
MT-300 CASSETTE HOLDER
K941600 · Medtec, Inc. · Sep 1994
FUJI ULTIMA EC-MA CASSETTE
K942481 · Fujifilm Medical System U.S.A., Inc. · Jul 1994
K945328 · JPI X-RAY FILM CASSETTE
Download PDF Jpi America, Inc.