Cleared Traditional

K914728 - KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM

K914728 is an FDA 510(k) clearance for KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM, manufactured by Eastman Kodak Company. The device is a Class 1 Radiology device with product code LMB cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K914728 · Eastman Kodak Company · Radiology device
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Mar 1992
Decision
133d
Days
Class 1
Risk

K914728 is an FDA 510(k) clearance for the KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM. Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2010 - 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

FDA 510(k) Submission Details - K914728

510(k) Number K914728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1991
Decision Date March 02, 1992
Days to Decision 133 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 107d · This submission: 133d
Pathway characteristics
Predicate-based equivalence.

LMB Device Classification - Class 1, General Controls

Product Code LMB Device, Digital Image Storage, Radiological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2010
Definition Medical Image Storage Hardware Is A Device That Provides Electronic Maintenance And Access Functions For Medical Images.
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 - LMB Device, Digital Image Storage, Radiological

All 33
Devices cleared under the same product code (LMB) and FDA review panel - the closest regulatory comparables to K914728.
OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS
K952888 · Olympus America, Inc. · Sep 1995
NICOM DIGITAL IMAGE MANAGER
K945654 · Camtronics, Ltd. · Feb 1995
DIGITAL DISK RECORDER
K933115 · Eigen · Apr 1994
DOPPLER UPGRADE FOR AUSONICS OPUS 1 REAL TIME SCAN
K905488 · Ausonics Pty , Ltd. · Dec 1991
OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM
K901118 · Adac Laboratories · Apr 1990
KODAK EKTASCAN IMAGE MANAGER
K891690 · Eastman Kodak Company · Jun 1989