Cleared Traditional

K933408 - FUJI DAYLIGHT CASSETTE MULTI-LOADER

K933408 is the FDA 510(k) clearance for FUJI DAYLIGHT CASSETTE MULTI-LOADER by Fujifilm Medical System U.S.A., Inc.. It is a Class 2 Radiology device (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
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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.

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

Submission Details

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.

Device Classification

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 42
Devices cleared under the same product code (IXW) and FDA review panel - the closest regulatory comparables to K933408.
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