Cleared Traditional

K855002 - KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM

K855002 is the FDA 510(k) clearance for KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM by Eastman Kodak Company. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K855002 · Eastman Kodak Company · Radiology device
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Apr 1986
Decision
115d
Days
Class 2
Risk

K855002 is an FDA 510(k) clearance for the KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on April 7, 1986 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Eastman Kodak Company devices

Submission Details

510(k) Number K855002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1985
Decision Date April 07, 1986
Days to Decision 115 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 107d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1127
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K855002.
KODAK EKTASCAN IMAGE TRANS SYS T1/R1 SOFTWARE,1.10
K864927 · Eastman Kodak Company · Feb 1987
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K863132 · General Electric Co. · Jan 1987
DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE
K861429 · Siemens Gammasonics, Inc. · Jul 1986
ADAC DPS-4070 DIGITAL RADIOGRAPHY SYS
K843708 · Adac Laboratories · Apr 1985
DIGITAL FLUOROGRAPHIC IMAGING SYSTEM DIGIFORMER
K844037 · Toshiba Medical Systems · Mar 1985
ADAC MODEL DPS-3300M DIGITAL PROCESSING SYSTEM
K844298 · Adac Laboratories · Mar 1985