Cleared Traditional

K033377 - FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033377 · Fujifilm Medical System U.S.A., Inc. · Radiology device
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Jan 2004
Decision
79d
Days
Class 2
Risk

K033377 is an FDA 510(k) clearance for the FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Fujifilm Medical System U.S.A., Inc. (Stamford, US). The FDA issued a Cleared decision on January 9, 2004 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2040 - 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 K033377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2003
Decision Date January 09, 2004
Days to Decision 79 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 107d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LMC Camera, Multi Format, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2040
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.