Cleared Traditional

K891690 - KODAK EKTASCAN IMAGE MANAGER

K891690 is an FDA 510(k) clearance for KODAK EKTASCAN IMAGE MANAGER, 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 85-day FDA review.

K891690 · Eastman Kodak Company · Radiology device
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Jun 1989
Decision
85d
Days
Class 1
Risk

K891690 is an FDA 510(k) clearance for the KODAK EKTASCAN IMAGE MANAGER. 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 June 15, 1989 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K891690

510(k) Number K891690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1989
Decision Date June 15, 1989
Days to Decision 85 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
22d faster than avg
Panel avg: 107d · This submission: 85d
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 54
Devices cleared under the same product code (LMB) and FDA review panel - the closest regulatory comparables to K891690.
ANGIOTEC IMAGE MANAGEMENT SYSTEM
K903806 · Andros Analyzers, Inc. · Nov 1990
DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)
K901956 · Eigen · Jul 1990
OMNIVIEW DIGITAL RADIOLOGY IMAGING SYSTEM
K901118 · Adac Laboratories · Apr 1990
PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM
K885327 · Philips Medical Systems North America, Inc. · May 1989
ANGIOTEC FMX-2220 SYSTEM
K891485 · Andros Analyzers, Inc. · May 1989
IMS-3 PICTURE ARCHIVING SYSTEM
K884990 · The Biomedical Engineering Center · Mar 1989
K891690 · KODAK EKTASCAN IMAGE MANAGER
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