Cleared Traditional

K911405 - KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T

K911405 is the FDA 510(k) clearance for KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T by Eastman Kodak Company. It is a Class 1 Radiology device (product code LMD) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K911405 · Eastman Kodak Company · Radiology device
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Apr 1991
Decision
25d
Days
Class 1
Risk

K911405 is an FDA 510(k) clearance for the KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T. 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 April 23, 1991 after a review of 25 days - a notably fast clearance cycle.

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: 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 K911405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1991
Decision Date April 23, 1991
Days to Decision 25 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
82d faster than avg
Panel avg: 107d · This submission: 25d
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 27
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K911405.
3M DIGITAL DISK INTERFACE UNIT
K920268 · 3M Company · May 1992
SIENET ARCHIVE SERVER, ISA I, ISA II STORAGE SERVE
K920310 · Siemens Gammasonics, Inc. · Mar 1992
PHILIPS TELESCAN
K911773 · Philips Medical Systems, Inc. · Jun 1991
PACSNET RESEARCH TOOLKIT
K905199 · Siemens Gammasonics, Inc. · Jan 1991
DU PONT LINX LASER IMAGER W/THE LINX NETWORKING
K900935 · E.I. Dupont DE Nemours & Co., Inc. · May 1990
MEDI-TRACE THERMAL VIDEO FILM PAPER
K891192 · Graphic Controls Corp. · Apr 1989