Cleared Traditional

K042158 - KODAK MEDICAL IMAGER 300

K042158 is an FDA 510(k) clearance for KODAK MEDICAL IMAGER 300, manufactured by Eastman Kodak Company. The device is a Class 2 Radiology device with product code LMC cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K042158 · Eastman Kodak Company · Radiology device
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Sep 2004
Decision
45d
Days
Class 2
Risk

K042158 is an FDA 510(k) clearance for the KODAK MEDICAL IMAGER 300. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Eastman Kodak Company (Oakdale, US). The FDA issued a Cleared decision on September 24, 2004 after a review of 45 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 Eastman Kodak Company devices

FDA 510(k) Submission Details - K042158

510(k) Number K042158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2004
Decision Date September 24, 2004
Days to Decision 45 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
62d faster than avg
Panel avg: 107d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LMC Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LMC Camera, Multi Format, Radiological

All 73
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K042158.
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K042159 · Eastman Kodak Company · Sep 2004
KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY
K033821 · Eastman Kodak Company · Feb 2004
FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L
K033377 · Fujifilm Medical System U.S.A., Inc. · Jan 2004