Cleared Traditional

K932565 - FUJIFILM EC-B SERIES CASETTE

K932565 is the FDA 510(k) clearance for FUJIFILM EC-B SERIES CASETTE by Fujifilm Medical System U.S.A., Inc.. It is a Class 2 Radiology device (product code IXA) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K932565 · Fujifilm Medical System U.S.A., Inc. · Radiology device
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Jul 1993
Decision
60d
Days
Class 2
Risk

K932565 is an FDA 510(k) clearance for the FUJIFILM EC-B SERIES CASETTE. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on July 26, 1993 after a review of 60 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.

View all Fujifilm Medical System U.S.A., Inc. devices

Submission Details

510(k) Number K932565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1993
Decision Date July 26, 1993
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 107d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 23
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K932565.
MT-300 CASSETTE HOLDER
K941600 · Medtec, Inc. · Sep 1994
FUJI ULTIMA EC-MA CASSETTE
K942481 · Fujifilm Medical System U.S.A., Inc. · Jul 1994
NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY CASSETTE HOLDERS
K935397 · Victoreen, Inc. · Dec 1993
DU PONT MV DARKROOM CASSETTE
K931074 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1993
MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER
K923334 · Cook, Inc. · Jan 1993
KODAK INSIGHT PORTABLE IMAGING SYSTEM
K921826 · Eastman Kodak Company · Aug 1992