Cleared Traditional

K936116 - KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS

K936116 is an FDA 510(k) clearance for KODAK EKTASCAN NETWORK INTERFACE/FOR OT..., manufactured by Eastman Kodak Company. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K936116 · Eastman Kodak Company · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
127d
Days
Class 1
Risk

K936116 is an FDA 510(k) clearance for the KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS. 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 29, 1994 after a review of 127 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.

FDA 510(k) Submission Details - K936116

510(k) Number K936116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1993
Decision Date April 29, 1994
Days to Decision 127 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
20d slower than avg
Panel avg: 107d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

LMD Device Classification - Class 1, General Controls

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 141
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K936116.
MEDICAL IMAGING WORKSTATION II (MIW II)
K941203 · Cemco, Inc. · Jun 1994
REMOTE CONSOLE
K940408 · Robinson Engineering Teleradiology System · Jun 1994
3M 1156 MULTI-INPUT SYSTEM
K936153 · 3M Information,Imaging and Electronic Sector · May 1994
VISIONLINK ACR-NEMA CONVERSION UTILITIES
K935103 · Evergreen Technologies, Inc. · Feb 1994
IMPAX 5000
K934386 · Heraeus Kulzer, Inc. · Jan 1994
MAXIVIEW DIAGNOSTIC WORKSTATION
K930500 · Dimensional Medicine, Inc. · Dec 1993
K936116 · KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS
Download PDF FDA Summary Eastman Kodak Company