Cleared Traditional

K933408 - FUJI DAYLIGHT CASSETTE MULTI-LOADER

K933408 is an FDA 510(k) clearance for FUJI DAYLIGHT CASSETTE MULTI-LOADER, manufactured by Fujifilm Medical System U.S.A., Inc.. The device is a Class 2 Radiology device with product code IXW cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K933408 · 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
Aug 1993
Decision
35d
Days
Class 2
Risk

K933408 is an FDA 510(k) clearance for the FUJI DAYLIGHT CASSETTE MULTI-LOADER. Classified as Processor, Radiographic-film, Automatic (product code IXW), Class II - Special Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on August 16, 1993 after a review of 35 days - a notably fast clearance cycle.

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: 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 - K933408

510(k) Number K933408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1993
Decision Date August 16, 1993
Days to Decision 35 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
72d faster than avg
Panel avg: 107d · This submission: 35d
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 82
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K933408.
KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSOR
K931314 · Konica Medical Corp. · Sep 1993
MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR
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AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033
K931883 · Alphatek Corp. · Aug 1993
AFP 17 X 4 AUTOMATIC FILM PROCESSOR
K925885 · Afp Imaging Corp. · Jun 1993
KODAK EKTASCAN
K923554 · Eastman Kodak Company · Feb 1993
AX-700LE AUTOMATIC X-RAY FILM PROCESSOR
K925569 · Alphatek Corp. · Jan 1993
K933408 · FUJI DAYLIGHT CASSETTE MULTI-LOADER
Download PDF FDA Summary Fujifilm Medical Syst…