Cleared Traditional

K002146 - KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY (FDA 510(k) Clearance)

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

K002146 · Eastman Kodak Company · Radiology device
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Sep 2000
Decision
72d
Days
Class 2
Risk

K002146 is an FDA 510(k) clearance for the KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY. 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 27, 2000 after a review of 72 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

Submission Details

510(k) Number K002146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2000
Decision Date September 27, 2000
Days to Decision 72 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
35d faster than avg
Panel avg: 107d · This submission: 72d
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.