Cleared Traditional

K942481 - FUJI ULTIMA EC-MA CASSETTE

K942481 is an FDA 510(k) clearance for FUJI ULTIMA EC-MA CASSETTE, manufactured by Fujifilm Medical System U.S.A., Inc.. The device is a Class 2 Radiology device with product code IXA cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K942481 · Fujifilm Medical System U.S.A., Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
65d
Days
Class 2
Risk

K942481 is an FDA 510(k) clearance for the FUJI ULTIMA EC-MA CASSETTE. 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 29, 1994 after a review of 65 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 - K942481

510(k) Number K942481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1994
Decision Date July 29, 1994
Days to Decision 65 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
42d faster than avg
Panel avg: 107d · This submission: 65d
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 50
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K942481.
JPI X-RAY FILM CASSETTE
K945328 · Jpi America, Inc. · Jan 1995
MCI OPTONIX CASSETTE OKAMOTO CASSETE
K945039 · Mci Optonix, Inc. · Nov 1994
MT-300 CASSETTE HOLDER
K941600 · Medtec, Inc. · Sep 1994
CRONEX REGULAR CASSETTE
K941475 · Dupont Medical Products · Jul 1994
DUPONT CRONEX PORTABLE GRID CASSETTE
K941518 · Dupont Medical Products · Jun 1994
NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY CASSETTE HOLDERS
K935397 · Victoreen, Inc. · Dec 1993
K942481 · FUJI ULTIMA EC-MA CASSETTE
Download PDF FDA Summary Fujifilm Medical Syst…