Cleared Traditional

KODAK EKTASCAN IMAGELINK SYSTEM (KEIS) (K931551) - FDA 510(k) Clearance

Class I Radiology device.

K931551 · Eastman Kodak Company · Radiology device
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Jun 1993
Decision
92d
Days
Class 1
Risk

K931551 is an FDA 510(k) clearance for the KODAK EKTASCAN IMAGELINK SYSTEM (KEIS). Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on June 29, 1993 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2020 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Eastman Kodak Company devices

Submission Details

510(k) Number K931551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1993
Decision Date June 29, 1993
Days to Decision 92 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
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LMD System, Digital Image Communications, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2020
Definition A Medical Image Communications Device Provides Electronic Transfer Of Medical Image Data Between Medical Devices. It May Include A Physical Communications Medium, Modems, Interfaces, And A Communications Protocol. It May Provide Simple Image Review Software Functionality For Medical Image Processing And Manipulation, Such As Grayscale Window And Level, Zoom And Pan, User Delineated Geometric Measurements, Compression, Or User Added Image Annotations. The Device Does Not Perform Advanced Image Processing Or Complex Quantitative Functions.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LMD System, Digital Image Communications, Radiological

All 13
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K931551.
KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER
K960382 · Eastman Kodak Company · Apr 1996
SIENET SPI SPOOLER
K953552 · Siemens Medical Solutions USA, Inc. · Oct 1995
KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS
K936116 · Eastman Kodak Company · Apr 1994
3M DIGITAL DISK INTERFACE UNIT
K920268 · 3M Company · May 1992
KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T
K911405 · Eastman Kodak Company · Apr 1991
DU PONT LINX LASER IMAGER W/THE LINX NETWORKING
K900935 · E.I. Dupont DE Nemours & Co., Inc. · May 1990