Cleared Traditional

K972380 - KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)
(FDA 510(k) Clearance)

K972380 · Eastman Kodak Company · Radiology

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), a Device, Digital Image Storage, Radiological (Class I — General Controls, product code LMB), submitted by Eastman Kodak Company (Dallas, US). The FDA issued a Cleared decision on September 11, 1997, 77 days after receiving the submission on June 26, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2010.

Submission Details

510(k) Number	K972380 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	LMB — Device, Digital Image Storage, Radiological
Device Class	Class I — 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.