Cleared Traditional

K972380 - KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)

K972380 is an FDA 510(k) clearance for KODAK DIGITAL SCIENCE (KDS) MEDICAL IMA..., 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 77-day FDA review.

K972380 · Eastman Kodak Company · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
77d
Days
Class 1
Risk

K972380 is an FDA 510(k) clearance for the KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL). Classified as Device, Digital Image Storage, Radiological (product code LMB), Class I - General Controls.

Submitted by Eastman Kodak Company (Dallas, US). The FDA issued a Cleared decision on September 11, 1997 after a review of 77 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.

View all Eastman Kodak Company devices

FDA 510(k) Submission Details - K972380

510(k) Number K972380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1997
Decision Date September 11, 1997
Days to Decision 77 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
30d faster than avg
Panel avg: 107d · This submission: 77d
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 K972380.
PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS)
K980243 · Parameter Developments, Inc. · Apr 1998
OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE
K973463 · O Tech, Inc. · Dec 1997
ID. STORE (RELEASE 2.0)
K973413 · I.S.G. Technologies, Inc. · Nov 1997
TDK MEDICAL GRADE CD-R
K971848 · Tdk Electronics Corporation of America · Aug 1997
WISE IMAGE MANAGEMENT SYSTEM
K971451 · O Tech, Inc. · Jun 1997
ACCESSPOINT, MED E-MAIL, DICOM READER
K963936 · Biosound, Inc. · Mar 1997